Multi-event February 2023 FDA Recall Glimepiride by Accord Healthcare, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Accord Healthcare, Inc. on February 7, 2023 for the product Glimepiride. The FDA reported the reason for recall as cgmp deviations. The product was distributed in United States including Puerto Rico and Canada and the recall is currently terminated.

Reported Recall Events

D-0418-2023 TERMINATED D-0401-2023 TERMINATED D-0402-2023 TERMINATED D-0400-2023 TERMINATED D-0413-2023 TERMINATED D-0403-2023 TERMINATED D-0380-2023 TERMINATED D-0386-2023 TERMINATED D-0387-2023 TERMINATED D-0389-2023 TERMINATED D-0430-2023 TERMINATED D-0388-2023 TERMINATED D-0425-2023 TERMINATED D-0431-2023 TERMINATED D-0429-2023 TERMINATED D-0428-2023 TERMINATED D-0427-2023 TERMINATED D-0392-2023 TERMINATED D-0426-2023 TERMINATED D-0390-2023 TERMINATED D-0391-2023 TERMINATED D-0371-2023 TERMINATED D-0424-2023 TERMINATED D-0406-2023 TERMINATED D-0375-2023 TERMINATED D-0385-2023 TERMINATED D-0404-2023 TERMINATED D-0370-2023 TERMINATED D-0373-2023 TERMINATED D-0398-2023 TERMINATED D-0378-2023 TERMINATED D-0420-2023 TERMINATED D-0393-2023 TERMINATED D-0382-2023 TERMINATED D-0412-2023 TERMINATED D-0394-2023 TERMINATED D-0377-2023 TERMINATED D-0396-2023 TERMINATED D-0384-2023 TERMINATED D-0423-2023 TERMINATED D-0381-2023 TERMINATED D-0408-2023 TERMINATED D-0407-2023 TERMINATED D-0395-2023 TERMINATED D-0374-2023 TERMINATED D-0376-2023 TERMINATED D-0410-2023 TERMINATED D-0399-2023 TERMINATED D-0365-2023 TERMINATED D-0405-2023 TERMINATED D-0416-2023 TERMINATED D-0372-2023 TERMINATED D-0397-2023 TERMINATED D-0366-2023 TERMINATED D-0367-2023 TERMINATED D-0421-2023 TERMINATED D-0409-2023 TERMINATED D-0383-2023 TERMINATED D-0422-2023 TERMINATED D-0379-2023 TERMINATED D-0368-2023 TERMINATED D-0411-2023 TERMINATED D-0369-2023 TERMINATED D-0419-2023 TERMINATED D-0414-2023 TERMINATED D-0417-2023 TERMINATED D-0415-2023 TERMINATED

Recall Number: D-0418-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
821 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. Packet NDC 16729-521-63, UPC 3 16729 52163 5; Carton NDC 16729-521-11, UPC 3 16729 52111 6.

Batch or Lot Expiration Information

Batch# Batches: R2100308, Exp. Date 2/28/2023

Recall Number: D-0401-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
9,888 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; Vial NDC 16729-464-63, UPC 3 16729 46463 5; Carton NDC 16729-464-08, UPC 3 16729 46408 6

Batch or Lot Expiration Information

Batch# Batches: R2101555, R2101538, R2101564, Exp. Date 11/30/2023

Recall Number: D-0402-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
5,090 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; Vial NDC 16729-465-31, UPC 3 16729 46531 1; Carton NDC 16729-465-03, UPC 3 16729 46503 8

Batch or Lot Expiration Information

Batch# Batches: R2101570, R2101574, R2101576, Exp. Date 11/30/2023

Recall Number: D-0400-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
665,469 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 11910 8; b) 90-count bottle NDC 16729-119-15 UPC 3 16729 11915 3; c) 1,000-count bottle NDC 16729-119-17 UPC 3 16729 11917 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

Batch or Lot Expiration Information

Batch# Batches: a) R2000831, Exp. Date 11/30/2023; R2000832, Exp. Date 11/30/2023; R2200661, Exp. Date 5/31/2025; b)R2000836, R2000837, R2000838, R2000840, R2000842, R2000835, R2000841, R2000833, Exp. Date 11/30/2023; R2100310, R2100311, R2100314, R2100312, R2100313, R2100315, R2100316, R2100317, R2100318, Exp. Date 2/29/2024; R2100859, Exp. Date 5/31/2024; R2100940, R2100993, Exp. Date 7/31/2024; c) R2000473, Exp. Date 8/31/2023; R2000517, Exp. Date 9/30/2023; R2100036, R2100005, R2100037, R2100002, R2100040, R2100044, R2100045, R2100039, R2100038, R2100104, R2100047, R2100048, R2100046, R2100049, R2100056, R2100057, R2100101, R2100058, R2100050, R2100103, R2100102, R2100116, R2100108, R2100105, R2100123, R2100117, R2100118, R2100121, R2100122, R2100128, R2100119, R2100124, Exp. Date 12/31/2023; R2100124, R2100182, R2100184, R2100183, R2100188, R2100189, R2100186, R2100222, R2100197, R2100198, R2100203, R2100192, R2100196, R2100202, R2100199, R2100200, R2100223, R2100224, R2100225, R2100226, R2100228, R2100245, R2100227, R2100230, R2100229, Exp. Date 1/31/2024; R2100246, R2100253, R2100249, R2100251, R2100248, R2100263, R2100254, R2100264, R2100265, R2100266, R2100255, R2100256, R2100257,Exp. Date 2/29/2024; R2100445, R2100446, R2100449, R2100450, R2100451, Exp. Date 3/31/2024; R2100544, R2100545, R2100549, R2100550, R2100567, R2100568, R2100574, R2100576, R2100577, Exp. Date 4/30/2024; R2100594, R2100610, R2100600, R2100624, R2100626, R2100662, R2100661, R2100629, R2100776, R2100693, R2100681, R2100684, Exp. Date 5/31/2024; R2100725, R2100724, R2100726, R2100816, R2100804, R2100815, R2100834, R2100841, Exp. Date 6/30/2024; R2200188, R2200196, R2200195, Exp. Date 1/31/2025; R2200368, R2200366, R2200503, Exp. Date 3/31/2025; R2200659, R2200660, R2200751, R2200759, R2200761, R2200763, Exp. Date 5/31/2025; R2201016, R2201014, Exp. Date 7/31/2025

Affected Packages Involved in this Recall

16729-119-10 Montelukast Sodium
16729-119-15 Montelukast Sodium
16729-119-17 Montelukast Sodium

Recall Number: D-0413-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
48,089 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose vial in 10x10 carton, Rx Only, Manufactured for: Accord Healthcare, Inc. USA. Manufactured by: Intas Pharmaceuticals Limited, India, Vial NDC 16729-493-03, UPC 3 16729 49303 1; Carton NDC 16729-493-45, UPC 3 16729 49345 1.

Batch or Lot Expiration Information

Batch# Batches: R2101372, R2101397, R2101404, Exp. Date 4/30/2023; R2200264, R2200270, Exp. Date 8/31/2023; R2200382, Exp. Date 9/30/2023; R2200849, Exp. Date 12/31/2023; R2201017, R2201138, Exp. Date 1/31/2024; R2201249, Exp. Date 2/29/2024

Recall Number: D-0403-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
37,691 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA; NDC 16729-466-03, UPC 3 16729 46603 5

Batch or Lot Expiration Information

Batch# Batches: R2101591, R2101590, R2101599, Exp. Date 11/30/2023

Recall Number: D-0380-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
1,420,988 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC 16729-218-10 UPC 3 16729 21810 8; b) 90-count bottles NDC 16729-218-15 UPC 3 16729 21815 3; c) 500-count bottles, NDC 16729-218-16, UPC 3 16729 21816 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

Batch or Lot Expiration Information

Batch# Batches: a) P2001925, Exp. Date 3/31/2023; P2003532, Exp. Date 6/30/2023; P2004847, Exp. Date 7/31/2023; R2000856, Exp. Date 11/30/2023; P2100452, Exp. Date 12/31/2023; P2100898, Exp. Date 1/31/2024; P2106273, Exp. Date 9/30/2024; b) R2000578, Exp. Date 7/31/2023; R2000653, Exp. Date 9/30/2023; R2000652, Exp. Date 9/30/2023; R2000826, Exp. Date 10/31/2023; R2000852, Exp. Date 10/31/2023; R2000853, Exp. Date 10/31/2023; R2000827, Exp. Date 11/30/2023; P2100102, Exp. Date,12/31/2023; P2100004, Exp. Date 12/31/2023; P2100450, Exp. Date 12/31/2023; P2100449, Exp. Date 12/31/2023; c)P2001392, P2001393, P2001395, P2001396, P2001397, P2001492, P2001493, P2001494, P2001495, Exp. Date 2/28/2023; P2001863, P2001864, P2001865, P2001924, P2001866, P2001926, P2001927, P2002072, P2002073, P2002071, P2002074, P2002075, P2002392, Exp. Date 3/31/2023; P2002230, P2002233, P2002234, P2002235, P2002274, P2002400, P2002399, P2002398, P2002479, P2002478, P2002481, P2002480, P2002482, P2002483, Exp. Date 4/30/2023; P2002759, P2002758, P2002755, P2002756, P2003058, P2003059, P2003061, P2003060, P2003062, P2003055, Exp. Date 5/31/2023; P2003533, P2003534, P2003535, P2003675, P2003537, P2003536, P2003676, P2003677, P2003678, P2003679, P2003680, P2003909, P2003910, Exp. Date 6/30/2023; P2004010, P2004008, P2004009, P2004232, P2004233, P2004234, Exp. Date 7/31/2023; P2004576, P2004838, R2000614, R2000624, R2000623, R2000615, R2000638, R2000637, R2000642, R2000640, Exp. Date 8/31/2023; R2000644, R2000662, R2000664, R2000643, R2000667, R2000666, R2000670, R2000671, R2000672, P2005692, P2005656, P2005693, P2005691, P2005694, Exp. Date 9/30/2023; P2005840, P2005841, P2005842, P2005843, P2005844, P2005870, P2005925, P2005923, P2005924, P2006007, P2006009, P2006010, P2005845, P2006008, P2006065, Exp. Date 10/31/2023; R2100003, R2100008, R2100010, R2100015, R2100016, R2100017, R2100018, R2100031, R2100022, R2100024, R2100069, R2100070, R2100071, R2100084, R2100080, R2100083, R2100078, R2100082, R2100093, Exp. Date 11/30/2023; P2100109, P2100304, P2100107, P2100103, P2100106, P2100108, P2100305, Exp. Date 12/31/2023; P2100718, P2100721, P2100720, P2100748, Exp. Date 1/31/2024; P2104140, Exp. Date 6/30/2024; P2104861, P2104860, P2104859, P2104866, Exp. Date 7/31/2024

Recall Number: D-0386-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
44,068 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Doxazosin Tablets USP 1 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-211-01 UPC 3 16729 21101 7; b) 1,000-count bottle NDC 16729-211-17 UPC 3 16729 21117 8; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

Batch or Lot Expiration Information

Batch# Batches: a) R2200402, Exp. Date 5/31/2024; R2200642, Exp. Date 5/31/2024; R2200643 Exp. Date 8/31/2024; R2201300 Exp. Date 8/31/2024; b) R2200403, Exp. Date 5/31/2024

Affected Packages Involved in this Recall

16729-414-01 Doxazosin
16729-414-17 Doxazosin
16729-211-01 Doxazosin
16729-211-17 Doxazosin
16729-213-01 Doxazosin
16729-213-17 Doxazosin
16729-415-01 Doxazosin
16729-415-17 Doxazosin

Recall Number: D-0387-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
69,122 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Doxazosin Tablets USP, 2 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-414-01 UPC 3 16729 41401 2; b) 1,000-count NDC 16729-414-17 UPC 3 16729 41417 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

Batch or Lot Expiration Information

Batch# Batches: a) R2200401, Exp. Date 5/31/2024; R2200675, Exp. Date 5/31/2024; R2200676 Exp. Date 11/30/2024; R2201070, Exp. Date 7/31/2025; b) R2200680, Exp. Date 9/30/2024

Affected Packages Involved in this Recall

16729-414-01 Doxazosin
16729-414-17 Doxazosin
16729-211-01 Doxazosin
16729-211-17 Doxazosin
16729-213-01 Doxazosin
16729-213-17 Doxazosin
16729-415-01 Doxazosin
16729-415-17 Doxazosin

Recall Number: D-0389-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
31,116 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Doxazosin Tablets USP, 8 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-415-01 UPC 3 16729 41501 9; b) 1,000 Tablets NDC 16729-415-17 UPC 3 16729 41517 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

Batch or Lot Expiration Information

Batch# Batches: a) R2200672, Exp. Date 5/31/2024; R2200673, Exp. Date 9/30/2024; R2201097, Exp. Date 7/31/2025; b) R2200678, Exp. Date 10/31/2024

Affected Packages Involved in this Recall

16729-414-01 Doxazosin
16729-414-17 Doxazosin
16729-211-01 Doxazosin
16729-211-17 Doxazosin
16729-213-01 Doxazosin
16729-213-17 Doxazosin
16729-415-01 Doxazosin
16729-415-17 Doxazosin

Recall Number: D-0430-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
8,184 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-237-01, UPC 3 16729 23701 7

Batch or Lot Expiration Information

Batch# Batches: P2106136, Exp. Date 8/31/2023, P2106813, P2106814, Exp. Date 9/30/2023, P2202764, Exp. Date 4/30/2024

Affected Packages Involved in this Recall

16729-232-01 Ropinirole
16729-233-01 Ropinirole
16729-234-01 Ropinirole
16729-235-01 Ropinirole
16729-236-01 Ropinirole
16729-237-01 Ropinirole
16729-238-01 Ropinirole

Recall Number: D-0388-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
75,190 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Doxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-213-01 UPC 3 16729 21301 1; b) 1,000-count bottle NDC 16729-213-17 UPC 3 16729 21317 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

Batch or Lot Expiration Information

Batch# Batches: a) R2200352, Exp. Date 5/31/2024; R2200356, Exp. Date 8/31/2024; R2200357, Exp. Date 8/31/2024; R2200633, Exp. Date 4/30/2025; R2200634, Exp. Date 4/30/2025; b) R2200677,Exp. Date 8/31/2024; R2200572,Exp. Date 4/30/2025; R2200571, Exp. Date 4/30/2025; R2200646, Exp. Date 4/30/2025

Affected Packages Involved in this Recall

16729-414-01 Doxazosin
16729-414-17 Doxazosin
16729-211-01 Doxazosin
16729-211-17 Doxazosin
16729-213-01 Doxazosin
16729-213-17 Doxazosin
16729-415-01 Doxazosin
16729-415-17 Doxazosin

Recall Number: D-0425-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
139,332 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-232-01, UPC 3 16729 23201 2;

Batch or Lot Expiration Information

Batch# Batches: P2102086, Exp. Date 3/31/2023; P2105094, P2105095, P2105097, P2105096, P2105093, Exp. Date 7/31/2023; P2106490, P2106491, P2106493, P2106492, P2106494, Exp. Date 9/30/2023; P2201069, P2201068, P2201067, Exp. Date 1/31/2024; P2203516, Exp. Date 5/31/2024

Affected Packages Involved in this Recall

16729-232-01 Ropinirole
16729-233-01 Ropinirole
16729-234-01 Ropinirole
16729-235-01 Ropinirole
16729-236-01 Ropinirole
16729-237-01 Ropinirole
16729-238-01 Ropinirole

Recall Number: D-0431-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
5,112 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-238-01, UPC 3 16729 23801 4

Batch or Lot Expiration Information

Batch# Batches: P2104150, P2104151, Exp. Date 6/30/2023, P2202065, Exp. Date 3/31/2024

Affected Packages Involved in this Recall

16729-232-01 Ropinirole
16729-233-01 Ropinirole
16729-234-01 Ropinirole
16729-235-01 Ropinirole
16729-236-01 Ropinirole
16729-237-01 Ropinirole
16729-238-01 Ropinirole

Recall Number: D-0429-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
14,928 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-236-01, UPC 3 16729 23601 0

Batch or Lot Expiration Information

Batch# Batches: P2105099, P2105098, Exp. Date 7/31/2023, P2106507, P2106508, P2106510, P2106509, Exp. Date 9/30/2023, P2202750, Exp. Date 4/30/2024

Affected Packages Involved in this Recall

16729-232-01 Ropinirole
16729-233-01 Ropinirole
16729-234-01 Ropinirole
16729-235-01 Ropinirole
16729-236-01 Ropinirole
16729-237-01 Ropinirole
16729-238-01 Ropinirole

Recall Number: D-0428-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
25,344 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-235-01, UPC 3 16729 23501 3

Batch or Lot Expiration Information

Batch# Batches: P2106370, P2106369, Exp. Date 9/30/2023, P2201254, Exp. Date 2/29/2024

Affected Packages Involved in this Recall

16729-232-01 Ropinirole
16729-233-01 Ropinirole
16729-234-01 Ropinirole
16729-235-01 Ropinirole
16729-236-01 Ropinirole
16729-237-01 Ropinirole
16729-238-01 Ropinirole

Recall Number: D-0427-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
104,945 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, NDC 16729-234-01, UPC 3 16729 23401 6

Batch or Lot Expiration Information

Batch# Batches: P2103544 Exp. Date 5/31/2023, P2106132, P2106131, P2106128, P2106129, P2106130, P2106133, Exp. Date 8/31/2023, P2107662, P2107663, P2107664, Exp. Date 11/30/2023, P2203543, Exp. Date 5/31/2024

Affected Packages Involved in this Recall

16729-232-01 Ropinirole
16729-233-01 Ropinirole
16729-234-01 Ropinirole
16729-235-01 Ropinirole
16729-236-01 Ropinirole
16729-237-01 Ropinirole
16729-238-01 Ropinirole

Recall Number: D-0392-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
2,731,365 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC 16729-090-10 UPC 3 16729 09010 0; b) 90-count bottles NDC 16729-090-15 UPC 3 16729 09015 5; c) 100-count bottles NDC 16729-090-01 UPC 3 16729 09001 8; d) 500-count bottles NDC 16729-090-16 UPC 3 16729 09016 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

Batch or Lot Expiration Information

Batch# Batches: a) P2001383, Exp. Date 2/28/2023; P2004886, Exp. Date 8/31/2023; P2100853, Exp. Date 11/30/2023; P2101652, Exp. Date 2/29/2024; P2101821, Exp. Date 2/29/2024; P2102146, Exp. Date 3/31/2024; P2107270, Exp. Date 10/31/2024; P2107939, Exp. Date 10/31/2024; P2201491, Exp. Date 2/28/2025; b) P2001377, Exp. Date 2/28/2023; P2005673, Exp. Date 9/30/2023; P2005911, Exp. Date 10/31/2023; P2005878, Exp. Date 10/31/2023; P2006076, Exp. Date 10/31/2023; P2006110,Exp. Date 10/31/2023; P2006830, Exp. Date 11/30/2023; P2100639, Exp. Date 1/31/2024; P2100640, Exp. Date 1/31/2024; P2104208, Exp. Date 6/30/2024; P2105388, Exp. Date 7/31/2024; P2105387, Exp. Date 7/31/2024; P2200316, Exp. Date 12/31/2024; P2200318, Exp. Date 12/31/2024; P2200317, Exp. Date 12/31/2024; P2200319, Exp. Date 12/31/2024; P2200820, Exp. Date 1/31/2025; P2200822, Exp. Date 1/31/2025; P2201492, Exp. Date 2/28/2025; P2201493, Exp. Date 2/28/2025; P2201758, Exp. Date 2/28/2025; P2201759, Exp. Date 2/28/2025; P2202107, Exp. Date 3/31/2025; c) P2001375, Exp. Date 2/28/2023; P2003258, Exp. Date 5/31/2023; P2005402, Exp. Date 9/30/2023; P2005497, Exp. Date 9/30/2023; P2100511, Exp. Date 12/31/2023; P2101047, Exp. Date 1/31/2024; P2104753, Exp. Date 6/30/2024; P2105389, Exp. Date 7/31/2024; P2107273, Exp. Date 10/31/2024; P2107276, Exp. Date 10/31/2024; P2107419, Exp. Date 10/31/2024; P2201757, Exp. Date 2/28/2025; d)P2001376, Exp. Date 2/28/2023; P2002182, Exp. Date 3/31/2023; P2002184, Exp. Date 3/31/2023; P2003254, Exp. Date 5/31/2023; P2003255, Exp. Date 5/31/2023; P2003256, Exp. Date 5/31/2023; P2003257, Exp. Date 5/31/2023; P2004403, Exp. Date 7/31/2023; P2004404, Exp. Date 7/31/2023; P2004416, Exp. Date 7/31/2023; P2004417, Exp. Date 7/31/2023; P2004526, Exp. Date 7/31/2023; P2004527, Exp. Date 7/31/2023; P2004841, Exp. Date 8/31/2023; P2004842, Exp. Date 8/31/2023; P2004885, Exp. Date 8/31/2023; P2004899, Exp. Date 8/31/2023; P2004901, Exp. Date 8/31/2023; P2005406, Exp. Date 9/30/2023; P2005498, Exp. Date 9/30/2023; P2005671, Exp. Date 9/30/2023; P2005675, Exp. Date 9/30/2023; P2005672, Exp. Date 9/30/2023; P2005860, Exp. Date 10/31/2023; P2006077, Exp. Date 10/31/2023; P2006079, Exp. Date 10/31/2023; P2006125, Exp. Date 10/31/2023; P2006081, Exp. Date 10/31/2023; P2006111, Exp. Date 10/31/2023; P2006832, Exp. Date 11/30/2023; P2006831, Exp. Date 11/30/2023; P2006833, Exp. Date 11/30/2023; P2006834, Exp. Date 11/30/2023; P2006835, Exp. Date 11/30/2023; P2100266, Exp. Date 12/31/2023; P2100268, Exp. Date 12/31/2023; P2100269, Exp. Date 12/31/2023; P2100637, Exp. Date 1/31/2024; P2100636, Exp. Date 1/31/2024; P2100638, Exp. Date 1/31/2024; P2100795, Exp. Date 1/31/2024; P2100797, Exp. Date 1/31/2024; P2100803, Exp. Date 1/31/2024; P2101048, Exp. Date 1/31/2024; P2100794, Exp. Date 1/31/2024; P2100796, Exp. Date 1/31/2024; P2101403, Exp. Date 2/28/2024; P2101404, Exp. Date 2/28/2024; P2101819, Exp. Date 2/28/2024; P2101653, Exp. Date 2/29/2024; P2101654, Exp. Date 2/29/2024; P2101818, Exp. Date 2/29/2024; P2101820, Exp. Date 2/29/2024; P2102022, Exp. Date 3/31/2024; P2102023, Exp. Date 3/31/2024; P2102024, Exp. Date 3/31/2024; P2102025, Exp. Date 3/31/2024; P2102026, Exp. Date 3/31/2024; P2102096, Exp. Date 3/31/2024; P2102097, Exp. Date 3/31/2024; P2102098, Exp. Date 3/31/2024; P2102145, Exp. Date 3/31/2024; P2102293, Exp. Date 3/31/2024; P2102294, Exp. Date 3/31/2024; P2102295, Exp. Date 3/31/2024; P2103218, Exp. Date 3/31/2024; P2102296, Exp. Date 3/31/2024; P2103063, Exp. Date 5/31/2024; P2103062, Exp. Date 5/31/2024; P2103064, Exp. Date 5/31/2024; P2103065, Exp. Date 5/31/2024; P2106836, Exp. Date 7/31/2024; P2106015, Exp. Date 8/31/2024; P2106017, Exp. Date 8/31/2024; P2106016, Exp. Date 8/31/2024; P2106020, Exp. Date 8/31/2024; P2106018, Exp. Date 8/31/2024; P2106019, Exp. Date 8/31/2024; P2106596, Exp. Date 9/30/2024; P2106597, Exp. Date 9/30/2024; P2106599, Exp. Date 9/30/2024; P2106598, Exp. Date 9/30/2024; P2106601, Exp. Date 9/30/2024; P2107420, Exp. Date 10/31/2024; P2107421, Exp. Date 10/31/2024; P2107423, Exp. Date 10/31/2024; P2107636, Exp. Date 11/30/2024; P2107635, Exp. Date 11/30/2024; P2107637, Exp. Date 11/30/2024; P2107638, Exp. Date 11/30/2024; P2107640, Exp. Date 11/30/2024; P2107641, Exp. Date 11/30/2024; P2107642, Exp. Date 11/30/2024; P2107756, Exp. Date 11/30/2024; P2107757, Exp. Date 11/30/2024; P2107840, Exp. Date 11/30/2024; P2107758, Exp. Date 11/30/2024; P2107841, Exp. Date 11/30/2024; P2107844, Exp. Date 11/30/2024; P2107843, Exp. Date 11/30/2024; P2107900, Exp. Date 11/30/2024; P2107902, Exp. Date 11/30/2024; P2107903, Exp. Date 11/30/2024; P2200313, Exp. Date 12/31/2024; P2200314, Exp. Date 12/31/2024; P2200823, Exp. Date 1/31/2025; P2200824, Exp. Date 1/31/2025; P2200825, Exp. Date 1/31/2025; P2201048, Exp. Date 1/31/2025; P2201049, Exp. Date 1/31/2025; P2201055, Exp. Date 1/31/2025; P2201051, Exp. Date 1/31/2025; P2201053, Exp. Date 1/31/2025; P2201494, Exp. Date 2/28/2025; P2201754, Exp. Date 2/28/2025; P2201755, Exp. Date 2/28/2025; P2202210, Exp. Date 2/28/2025; P2202235, Exp. Date 2/28/2025; P2201756, Exp. Date 2/28/2025; P2203018, Exp. Date 5/31/2025; P2203017, Exp. Date 5/31/2025; P2203015, Exp. Date 5/31/2025; P2203019, Exp. Date 5/31/2025; P2204008, Exp. Date 6/30/2025; P2204378, Exp. Date 6/30/2025; P2204010, Exp. Date 6/30/2025; P2204073, Exp. Date 6/30/2025

Affected Packages Involved in this Recall

16729-090-10 Finasteride
16729-090-15 Finasteride
16729-090-01 Finasteride
16729-090-16 Finasteride
16729-090-17 Finasteride

Recall Number: D-0426-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
181,848 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA. NDC 16729-233-01, UPC 3 16729 23301 9

Batch or Lot Expiration Information

Batch# Batches: P2102133, P2102135, P2102136, Exp. Date 3/31/2023, P2104998, P2104997, P2104991, P2104992, P2104990, P2104993, P2105000, P2104999, P2105002, P2105001, Exp. Date 7/31/2023, P2106812, Exp. Date, 9/30/2023, P2200433, P2200434, P2200435, Exp. Date, 12/31/2023, P2202730, P2202729, Exp. Date 4/30/2024, P2203517, Exp. Date 5/31/2024

Affected Packages Involved in this Recall

16729-232-01 Ropinirole
16729-233-01 Ropinirole
16729-234-01 Ropinirole
16729-235-01 Ropinirole
16729-236-01 Ropinirole
16729-237-01 Ropinirole
16729-238-01 Ropinirole

Recall Number: D-0390-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
325,356 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-089-10 UPC 3 16729 08910 4; b) 90-count bottle NDC 16729-089-15 UPC 3 16729 08915 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

Batch or Lot Expiration Information

Batch# Batches: a) P2005979, Exp. Date 10/31/2023; P2100252, Exp. Date 12/31/2023; P2101710, Exp. Date 2/29/2024; b) P2100253, Exp. Date 12/31/2023; P2103035, Exp. Date 4/30/2024; P2103036, Exp. Date 4/30/2024

Affected Packages Involved in this Recall

16729-089-10 Finasteride
16729-089-15 Finasteride

Recall Number: D-0391-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
1,440,652 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured for: Thirty Madison, Inc. New York, NY 10016 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 71713-096-90 UPC 3 71713 09690 2

Batch or Lot Expiration Information

Batch# Batches: P2005583, P2005584, P2005585, P2005527, P2005528, P2005586, Exp. Date 9/30/2023; P2005980, Exp. Date 10/31/2023; P2100396, P2100264, P2100263, Exp. Date 12/31/2023; P2101583, P2101711, P2101708, P2101584, Exp. Date 2/29/2024; P2102852, P2102851, P2102853, P2102854, P2102855, Exp. Date 4/30/2024; P2103993, P2103998, P2103997, P2103999, P2104205, P2104206, P2105631, P2105632, P2105546, P2105547, P2105548 Exp. Date 8/31/2024

Recall Number: D-0371-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
256,106 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC 3 16729 04415 8; b) 1,000 Tablets NDC 16729-044-17 UPC 3 16729 04417 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA.

Batch or Lot Expiration Information

Batch# Batches: a)R2100455, Exp. Date 3/31/2023; R2200274, Exp. Date 1/31/2024; R2200700, Exp. Date 5/31/2024; b) R2101342, R2101343, R2101476, Exp. Date 9/30/2023; R2101364, R2101365, R2101366, R2101367, Exp. Date 10/31/2023; R2101612, R2101613, R2101614, Exp. Date 11/30/2023; R2200222, R2200221, R2200223, Exp. Date 1/31/2024; R2200795, R2200713, R2200701, R2200711, R2200712, R2200756, R2200757, R2200754, R2200755, Exp. Date 5/31/2024; R2200945, R2200943, Exp. Date 6/30/2024

Affected Packages Involved in this Recall

16729-045-10 Atorvastatin Calcium
16729-045-15 Atorvastatin Calcium
16729-045-01 Atorvastatin Calcium
16729-045-16 Atorvastatin Calcium
16729-045-17 Atorvastatin Calcium
16729-044-10 Atorvastatin Calcium
16729-044-15 Atorvastatin Calcium
16729-044-01 Atorvastatin Calcium
16729-044-16 Atorvastatin Calcium
16729-044-17 Atorvastatin Calcium
16729-046-10 Atorvastatin Calcium
16729-046-15 Atorvastatin Calcium
16729-046-01 Atorvastatin Calcium
16729-046-16 Atorvastatin Calcium
16729-046-17 Atorvastatin Calcium
16729-047-10 Atorvastatin Calcium
16729-047-15 Atorvastatin Calcium
16729-047-01 Atorvastatin Calcium
16729-047-16 Atorvastatin Calcium
16729-047-17 Atorvastatin Calcium

Recall Number: D-0424-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
1970 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-011-15, UPC 3 16729 01115 0

Batch or Lot Expiration Information

Batch# Batches: R2201233, Exp. Date 4/30/2024

Affected Packages Involved in this Recall

16729-008-15 Pravastatin Sodium
16729-008-16 Pravastatin Sodium
16729-008-17 Pravastatin Sodium
16729-009-15 Pravastatin Sodium
16729-009-16 Pravastatin Sodium
16729-009-17 Pravastatin Sodium
16729-010-15 Pravastatin Sodium
16729-010-16 Pravastatin Sodium
16729-010-17 Pravastatin Sodium
16729-011-15 Pravastatin Sodium
16729-011-16 Pravastatin Sodium
16729-011-17 Pravastatin Sodium

Recall Number: D-0406-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
43,302 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle NDC 16729-286-15, UPC 3 16729 28615 2; b) 1,000-count bottles NDC 16729-286-17, UPC 3 16729 28617 6; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

Batch or Lot Expiration Information

Batch# Batches: a) P2006560, Exp. Date 11/30/2023; P2101562, Exp. Date 2/28/2024; b) P2006561, Exp. Date 11/30/2023; P2006562, Exp. Date 11/30/2023; P2006587, Exp. Date 11/30/2023; P2100035, Exp. Date 11/30/2023; P2006600, Exp. Date 11/30/2023; P2006603, Exp. Date 11/30/2023; P2006604, Exp. Date 11/30/2023; P2006605, Exp. Date 11/30/2023; P2006606, Exp. Date 11/30/2023; P2100542, Exp. Date 12/31/2023; P2100543, Exp. Date 12/31/2023; P2100544, Exp. Date 12/31/2023; P2100545, Exp. Date 12/31/2023; P2101485, Exp. Date 2/28/2024; P2101484, Exp. Date 2/29/2024; P2205235, Exp. Date 8/31/2025; P2205236, Exp. Date 8/31/2025

Affected Packages Involved in this Recall

16729-284-10 Rosuvastatin
16729-284-15 Rosuvastatin
16729-284-17 Rosuvastatin
16729-285-10 Rosuvastatin
16729-285-15 Rosuvastatin
16729-285-17 Rosuvastatin
16729-286-10 Rosuvastatin
16729-286-15 Rosuvastatin
16729-286-17 Rosuvastatin
16729-287-10 Rosuvastatin
16729-287-15 Rosuvastatin
16729-287-17 Rosuvastatin

Recall Number: D-0375-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
23,784 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
BusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-201-01

Batch or Lot Expiration Information

Batch# Batches: P2105532, Exp. Date 6/30/2024; P2200348, Exp. Date 12/31/2024

Affected Packages Involved in this Recall

16729-203-12 Buspirone Hydrochloride
16729-203-01 Buspirone Hydrochloride
16729-203-59 Buspirone Hydrochloride
16729-203-16 Buspirone Hydrochloride
16729-203-17 Buspirone Hydrochloride
16729-289-12 Buspirone Hydrochloride
16729-289-01 Buspirone Hydrochloride
16729-289-59 Buspirone Hydrochloride
16729-289-16 Buspirone Hydrochloride
16729-289-17 Buspirone Hydrochloride
16729-200-01 Buspirone Hydrochloride
16729-200-16 Buspirone Hydrochloride
16729-200-17 Buspirone Hydrochloride
16729-201-01 Buspirone Hydrochloride
16729-201-16 Buspirone Hydrochloride
16729-201-17 Buspirone Hydrochloride
16729-202-01 Buspirone Hydrochloride
16729-202-16 Buspirone Hydrochloride
16729-202-17 Buspirone Hydrochloride

Recall Number: D-0385-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
113,003 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA NDC 16729-492-12 UPC 3 16729 49212 6

Batch or Lot Expiration Information

Batch# Batches: P2101582, P2101661, P2101482, P2101686, Exp. Date 2/28/2023; P2102581, P2102598, Exp. Date 4/30/2023; P2103623, P2103653, P2103670, Exp. Date 5/31/2023; P2104463, P2104385, P2104386, P2104472, P2104709, P2104714, Exp. Date 6/30/2023; P2200797, P2200773, P2200831, Exp. Date 12/31/2023; P2201017, P2201081, P2201056, Exp. Date 1/31/2024; P2200819, Exp. Date 12/31/2024; P2202611, P2202616, Exp. Date 4/30/2025, P2203467, Exp. Date 5/31/2025

Affected Packages Involved in this Recall

16729-490-12 Dofetilide
16729-490-59 Dofetilide
16729-491-12 Dofetilide
16729-491-59 Dofetilide
16729-492-12 Dofetilide
16729-492-59 Dofetilide

Recall Number: D-0404-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
63,247 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-284-15, UPC 3 16729 28415 8; b) 1,000-count bottle, NDC 16729-284-17, UPC 3 16729 28417 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA.

Batch or Lot Expiration Information

Batch# Batches: a) P2101063, Exp. Date 1/31/2024; P2101707, Exp. Date 2/29/2024; P2203913 Exp. Date 6/30/2025; b) P2101064, Exp. Date 1/31/2024; P2101539, Exp. Date 1/31/2024; P2101709, Exp. Date 2/29/2024; P2102138, Exp. Date 2/29/2024; P2103186, Exp. Date 5/31/2024; P2104430, Exp. Date 6/30/2024; P2104703, Exp. Date 7/31/2024; P2104704, Exp. Date 7/31/2024; P2104705, Exp. Date 7/31/2024; P2104702, Exp. Date 7/31/2024; P2107176, Exp. Date 10/31/2024; P2107177, Exp. Date 10/31/2024; P2107178, Exp. Date 10/31/2024; P2107181, Exp. Date 10/31/2024; P2203915, Exp. Date 6/30/2025; P2203914, Exp. Date 6/30/2025; P2204998, Exp. Date 8/31/2025; P2204999, Exp. Date 8/31/202

Affected Packages Involved in this Recall

16729-284-10 Rosuvastatin
16729-284-15 Rosuvastatin
16729-284-17 Rosuvastatin
16729-285-10 Rosuvastatin
16729-285-15 Rosuvastatin
16729-285-17 Rosuvastatin
16729-286-10 Rosuvastatin
16729-286-15 Rosuvastatin
16729-286-17 Rosuvastatin
16729-287-10 Rosuvastatin
16729-287-15 Rosuvastatin
16729-287-17 Rosuvastatin

Recall Number: D-0370-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
88,728 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-10, UPC 3 16729 28310 6; b) 100-count bottle, NDC 16729-283-01, UPC 3 16729 28301 4; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India

Batch or Lot Expiration Information

Batch# Batches: a) P2005477, Exp. Date 9/30/2023; P2100002, Exp. Date 12/31/2023; P2101359 Exp. Date 2/28/2024; P2105409, Exp. Date 7/31/2024; P2107447, Exp. Date 10/31/2024; P2203388 Exp. Date 5/31/2025; b) P2101859 Exp. Date 2/28/2023; P2107056, Exp. Date 10/31/2023; P2203066, Exp. Date 5/31/2024; P2206130, Exp. Date 8/31/2024

Affected Packages Involved in this Recall

16729-278-10 Aripiprazole
16729-278-01 Aripiprazole
16729-278-16 Aripiprazole
16729-278-46 Aripiprazole
16729-279-10 Aripiprazole
16729-279-01 Aripiprazole
16729-279-16 Aripiprazole
16729-279-46 Aripiprazole
16729-280-10 Aripiprazole
16729-280-01 Aripiprazole
16729-280-16 Aripiprazole
16729-280-46 Aripiprazole
16729-281-10 Aripiprazole
16729-281-01 Aripiprazole
16729-281-16 Aripiprazole
16729-281-46 Aripiprazole
16729-282-10 Aripiprazole
16729-282-01 Aripiprazole
16729-282-16 Aripiprazole
16729-282-46 Aripiprazole
16729-283-10 Aripiprazole
16729-283-01 Aripiprazole
16729-283-16 Aripiprazole
16729-283-46 Aripiprazole

Recall Number: D-0373-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
147,736 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3 16729 04615 2; b) 1,000 Tablets NDC 16729-046-17 UPC 3 16729 04617 6, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

Batch or Lot Expiration Information

Batch# Batches: a)R2100552, R2100553, Exp. Date 4/30/2023; R2200253, Exp. Date 2/29/2024; R2200627, Exp. Date 4/30/2024; R2201113, Exp. Date 6/30/2024; R2201184, Exp. Date 8/31/2024; R2201366, Exp. Date 9/30/2024; b) R2200280, Exp. Date 2/29/2024; R2200385, R2200386, R2200491, R2200490, R2200494, R2200496, R2200495, Exp. Date 3/31/2024; R2200510, R2200520, R2200521, R2200517, R2200511, R2200632, R2200631, R2200637, R2200635, R2200648, R2200638, R2200639, R2200647, Exp. Date 4/30/2024; R2200727, Exp. Date 5/31/2024

Affected Packages Involved in this Recall

16729-045-10 Atorvastatin Calcium
16729-045-15 Atorvastatin Calcium
16729-045-01 Atorvastatin Calcium
16729-045-16 Atorvastatin Calcium
16729-045-17 Atorvastatin Calcium
16729-044-10 Atorvastatin Calcium
16729-044-15 Atorvastatin Calcium
16729-044-01 Atorvastatin Calcium
16729-044-16 Atorvastatin Calcium
16729-044-17 Atorvastatin Calcium
16729-046-10 Atorvastatin Calcium
16729-046-15 Atorvastatin Calcium
16729-046-01 Atorvastatin Calcium
16729-046-16 Atorvastatin Calcium
16729-046-17 Atorvastatin Calcium
16729-047-10 Atorvastatin Calcium
16729-047-15 Atorvastatin Calcium
16729-047-01 Atorvastatin Calcium
16729-047-16 Atorvastatin Calcium
16729-047-17 Atorvastatin Calcium

Recall Number: D-0398-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
3,164 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials carton, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 5mL vial NDC 16729-473-31 UPC 3 16729 47331 6; carton NDC 16729-473-03 UPC 3 16729 47303 3

Batch or Lot Expiration Information

Batch# Batches: R2200259, Exp. Date 2/29/2024, R2200258, Exp. Date 2/29/2024, R2200617, Exp. Date 4/30/2024, R2201308, Exp. Date 8/31/2024

Affected Packages Involved in this Recall

16729-471-08 Glycopyrrolate
16729-472-08 Glycopyrrolate
16729-473-03 Glycopyrrolate
16729-474-03 Glycopyrrolate
16729-474-05 Glycopyrrolate
16729-473-31 Glycopyrrolate

Recall Number: D-0378-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
3,784 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-202-16 UPC 3 16729 20216 9

Batch or Lot Expiration Information

Batch# Batches: P2105472, Exp. Date 4/30/2024

Affected Packages Involved in this Recall

16729-203-12 Buspirone Hydrochloride
16729-203-01 Buspirone Hydrochloride
16729-203-59 Buspirone Hydrochloride
16729-203-16 Buspirone Hydrochloride
16729-203-17 Buspirone Hydrochloride
16729-289-12 Buspirone Hydrochloride
16729-289-01 Buspirone Hydrochloride
16729-289-59 Buspirone Hydrochloride
16729-289-16 Buspirone Hydrochloride
16729-289-17 Buspirone Hydrochloride
16729-200-01 Buspirone Hydrochloride
16729-200-16 Buspirone Hydrochloride
16729-200-17 Buspirone Hydrochloride
16729-201-01 Buspirone Hydrochloride
16729-201-16 Buspirone Hydrochloride
16729-201-17 Buspirone Hydrochloride
16729-202-01 Buspirone Hydrochloride
16729-202-16 Buspirone Hydrochloride
16729-202-17 Buspirone Hydrochloride

Recall Number: D-0420-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
2641 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-468-15, UPC 3 16729 46815 2.

Batch or Lot Expiration Information

Batch# Batches: P2202519, P2202513 Exp. Date 4/30/2024

Affected Packages Involved in this Recall

16729-468-15 Pirfenidone
16729-468-64 Pirfenidone
16729-467-15 Pirfenidone
16729-467-85 Pirfenidone
16729-467-64 Pirfenidone

Recall Number: D-0393-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
469,944 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-001-01 UPC 3 16729 00101 4; b) 500-count bottle NDC 16729-001-16 UPC 3 16729 00116 8; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

Batch or Lot Expiration Information

Batch# Batches: a) R2000166, Exp. Date 4/30/2023, P2003528 Exp. Date 6/30/2023, P2005451 Exp. Date 8/31/2023, P2005438 Exp. Date 8/31/2023, P2005436 Exp. Date 8/31/2023, P2005437 Exp. Date 8/31/2023, P2005452 Exp. Date 8/31/2023, P2006055 Exp. Date 9/30/2023, P2101782 Exp. Date 2/28/2024, P2101783 Exp. Date 2/28/2024, P2101781 Exp. Date 2/29/2024, P2102171 Exp. Date 2/29/2024, P2101844 Exp. Date 3/31/2024, P2101846 Exp. Date 3/31/2024, P2101845 Exp. Date 3/31/2024; b) P2006510 Exp. Date 11/30/2023, P2100975 Exp. Date 1/31/2024, P2100625 Exp. Date 1/31/2024, P2101778 Exp. Date 2/29/2024, P2101779 Exp. Date 2/29/2024, P2103021 Exp. Date 4/30/2024, P2103020 Exp. Date 4/30/2024, R2100657 Exp. Date 5/31/2024, R2100656 Exp. Date 5/31/2024, R2100658 Exp. Date 5/31/2024, P2104735 Exp. Date 7/31/2024, P2104739 Exp. Date 7/31/2024, P2104737 Exp. Date 7/31/2024, P2104738 Exp. Date 7/31/2024, P2106260 Exp. Date 9/30/2024, P2107384 Exp. Date 9/30/2024, R2200045 Exp. Date 12/31/2024, R2200046 Exp. Date 12/31/2024, R2200054 Exp. Date 12/31/2024, R2200055 Exp. Date 12/31/2024, R2200057 Exp. Date 12/31/2024, R2200058 Exp. Date 12/31/2024, R2200053 Exp. Date 12/31/2024, R2200059 Exp. Date 12/31/2024, R2200056 Exp. Date 12/31/2024, P2201929 Exp. Date 2/28/2025, R2200663 Exp. Date 4/30/2025, P2203518 Exp. Date 5/31/2025, R2200897 Exp. Date 6/30/2025, R2200898 Exp. Date 6/30/2025, R2200899 Exp. Date 6/30/2025, P2205528 Exp. Date 8/31/2025

Affected Packages Involved in this Recall

16729-001-01 Glimepiride
16729-001-16 Glimepiride
16729-001-17 Glimepiride
16729-002-01 Glimepiride
16729-002-16 Glimepiride
16729-002-17 Glimepiride
16729-003-01 Glimepiride
16729-003-16 Glimepiride
16729-003-17 Glimepiride

Recall Number: D-0382-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
228,760 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-435-05 UPC 3 16729 43505 5.

Batch or Lot Expiration Information

Batch# Batches: R2101282, Exp. Date 9/30/2023; R2101600,Exp. Date 11/30/2024; R2200002, R2200028, R2200116, R2200142, R2200152, Exp. Date 12/31/2024; R2200165, R2200190, Exp. Date 1/31/2025; R2201042, Exp. Date 7/31/2025

Affected Packages Involved in this Recall

16729-435-05 Daptomycin

Recall Number: D-0412-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
205,631 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3; b) 1,000-count bottle NDC 16729-007-17, UPC 3 16729 00717 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

Batch or Lot Expiration Information

Batch# Batches: a) R2100387, R2100393, Exp. Date 2/28/2023, P2102556, P2102558, P2102636, Exp. Date 4/30/2023, P2103981, P2103877, P2103958, Exp. Date 5/31/2023, R2101393, R2101395, R2101394, Exp. Date 10/31/2023, P2202681, P2202653, Exp. Date 4/30/2025; b)R2000555, R2000587, R2000599, R2000604, Exp. Date 9/30/2023; P2100023, P2006857, Exp. Date 11/30/2023, P2101094, P2101096, P2101110, P2101111, P2101113, P2101145, P2101198, P2101223, P2101199, Exp. Date 1/31/2024, P2101877, P2101885, P2101886, P2101929, R2100402, R2100406, R2100403, Exp. Date 2/28/2024, P2101786, P2101787, P2101789, P2101790, Exp. Date 2/29/2024, R2100440, R2100439, Exp. Date 3/31/2024

Affected Packages Involved in this Recall

16729-005-10 Simvastatin
16729-005-12 Simvastatin
16729-005-15 Simvastatin
16729-005-17 Simvastatin
16729-006-10 Simvastatin
16729-006-12 Simvastatin
16729-006-15 Simvastatin
16729-006-17 Simvastatin
16729-007-10 Simvastatin
16729-007-12 Simvastatin
16729-007-15 Simvastatin
16729-007-17 Simvastatin
16729-156-10 Simvastatin
16729-156-15 Simvastatin
16729-156-17 Simvastatin
16729-004-10 Simvastatin
16729-004-12 Simvastatin
16729-004-15 Simvastatin
16729-004-17 Simvastatin

Recall Number: D-0394-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
992,622 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 00201 1; b) 500 Tablets NDC 16729-002-16 UPC 3 16729 00216 5; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

Batch or Lot Expiration Information

Batch# Batches: a) R2000184, Exp. Date 4/30/2023, R2000183 Exp. Date 4/30/2023, P2002969 Exp. Date 5/31/2023, P2002970 Exp. Date 5/31/2023, P2005346 Exp. Date 8/31/2023, P2005847 Exp. Date 10/31/2023, P2006133 Exp. Date 10/31/2023, P2100682 Exp. Date 1/31/2024, P2102065 Exp. Date 3/31/2024, P2102067 Exp. Date 3/31/2024, P2102068 Exp. Date 3/31/2024, P2102070 Exp. Date 3/31/2024, R2100659 Exp. Date 5/31/2024, R2100660 Exp. Date 5/31/2024, P2103898 Exp. Date 6/30/2024, P2106000 Exp. Date 7/31/2024, R2101442 Exp. Date 9/30/2024, P2201160 Exp. Date 1/31/2025, P2200695 Exp. Date 1/31/2025, P2200694 Exp. Date 1/31/2025; b) P2005530, Exp. Date 9/30/2023, P2005531 Exp. Date 9/30/2023, P2005532 Exp. Date 9/30/2023, P2005533 Exp. Date 9/30/2023, P2005846 Exp. Date 10/31/2023, P2006594 Exp. Date 11/30/2023, P2100602 Exp. Date 1/31/2024, P2100603 Exp. Date 1/31/2024, P2100604 Exp. Date 1/31/2024, P2100605 Exp. Date 1/31/2024, P2101571 Exp. Date 2/29/2024, P2101572 Exp. Date 2/29/2024, P2102046 Exp. Date 3/31/2024, P2102047 Exp. Date 3/31/2024, P2102049 Exp. Date 3/31/2024, P2102050 Exp. Date 3/31/2024, P2102051 Exp. Date 3/31/2024, P2102052 Exp. Date 3/31/2024, P2103017 Exp. Date 4/30/2024, P2103018 Exp. Date 4/30/2024, P2103900 Exp. Date 6/30/2024, P2104436 Exp. Date 6/30/2024, P2105399 Exp. Date 7/31/2024, P2105400 Exp. Date 7/31/2024, P2106257 Exp. Date 9/30/2024, P2106258 Exp. Date 9/30/2024, P2106259 Exp. Date 9/30/2024, R2101443 Exp. Date 9/30/2024, R2101445 Exp. Date 9/30/2024, R2101444 Exp. Date 9/30/2024, R2200082 Exp. Date 12/31/2024, R2200080 Exp. Date 12/31/2024, R2200079 Exp. Date 12/31/2024, R2200081 Exp. Date 12/31/2024, P2200691 Exp. Date 1/31/2025, P2200692 Exp. Date 1/31/2025, P2200693 Exp. Date 1/31/2025, P2201499 Exp. Date 2/28/2025, P2201498 Exp. Date 2/28/2025, R2200579 Exp. Date 4/30/2025, P2203881 Exp. Date 5/31/2025, P2203441 Exp. Date 5/31/2025, P2203442 Exp. Date 5/31/2025, R2200949 Exp. Date 6/30/2025, R2201094 Exp. Date 6/30/2025, R2201003 Exp. Date 7/31/2025

Affected Packages Involved in this Recall

16729-001-01 Glimepiride
16729-001-16 Glimepiride
16729-001-17 Glimepiride
16729-002-01 Glimepiride
16729-002-16 Glimepiride
16729-002-17 Glimepiride
16729-003-01 Glimepiride
16729-003-16 Glimepiride
16729-003-17 Glimepiride

Recall Number: D-0377-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
10992 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-203-01, UPC 3 16729 20301 2;

Batch or Lot Expiration Information

Batch# Batches: P2105483, Exp. Date 7/31/2024

Affected Packages Involved in this Recall

16729-203-12 Buspirone Hydrochloride
16729-203-01 Buspirone Hydrochloride
16729-203-59 Buspirone Hydrochloride
16729-203-16 Buspirone Hydrochloride
16729-203-17 Buspirone Hydrochloride
16729-289-12 Buspirone Hydrochloride
16729-289-01 Buspirone Hydrochloride
16729-289-59 Buspirone Hydrochloride
16729-289-16 Buspirone Hydrochloride
16729-289-17 Buspirone Hydrochloride
16729-200-01 Buspirone Hydrochloride
16729-200-16 Buspirone Hydrochloride
16729-200-17 Buspirone Hydrochloride
16729-201-01 Buspirone Hydrochloride
16729-201-16 Buspirone Hydrochloride
16729-201-17 Buspirone Hydrochloride
16729-202-01 Buspirone Hydrochloride
16729-202-16 Buspirone Hydrochloride
16729-202-17 Buspirone Hydrochloride

Recall Number: D-0396-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
23,814 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 1 ml vial NDC 16729-471-63 UPC 3 16729 47163 3; 25 x 1 mL carton NDC 16729-471-08 UPC 3 16729 47108 4

Batch or Lot Expiration Information

Batch# Batches: R2200436, Exp. Date 1/31/2024, R2200159, Exp. Date 1/31/2024, R2200166, Exp. Date 1/31/2024, R2200618, Exp. Date 4/30/2024, R2201290, Exp. Date 8/31/2024, R2201324, Exp. Date 8/31/2024

Affected Packages Involved in this Recall

16729-471-08 Glycopyrrolate
16729-472-08 Glycopyrrolate
16729-473-03 Glycopyrrolate
16729-474-03 Glycopyrrolate
16729-474-05 Glycopyrrolate
16729-471-63 Glycopyrrolate

Recall Number: D-0384-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
113,571 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA NDC 16729-491-12 UPC 3 16729 49112 9

Batch or Lot Expiration Information

Batch# Batches: P2101481 Exp. Date 2/28/2023; P2101985, P2101958, P2102019, Exp. Date 3/31/2023; P2102580, P2102597, Exp. Date 4/30/2023; P2104708, P2104712, Exp. Date 6/30/2023; P2107154, P2107187, Exp. Date 10/31/2023; P2107874, Exp. Date 11/30/2023; P2200772, P2200796, P2200830, Exp. Date 12/31/2023; P2201196, P2201198, Exp. Date 1/31/2024; P2200817, Exp. Date 12/31/2024; P2202610, Exp. Date 4/30/2025; P2203466, Exp. Date 5/31/2025

Affected Packages Involved in this Recall

16729-490-12 Dofetilide
16729-490-59 Dofetilide
16729-491-12 Dofetilide
16729-491-59 Dofetilide
16729-492-12 Dofetilide
16729-492-59 Dofetilide

Recall Number: D-0423-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
120 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-010-17, UPC 3 16729 01017 7

Batch or Lot Expiration Information

Batch# Batches: R2201294, Exp. Date 8/31/2025

Affected Packages Involved in this Recall

16729-008-15 Pravastatin Sodium
16729-008-16 Pravastatin Sodium
16729-008-17 Pravastatin Sodium
16729-009-15 Pravastatin Sodium
16729-009-16 Pravastatin Sodium
16729-009-17 Pravastatin Sodium
16729-010-15 Pravastatin Sodium
16729-010-16 Pravastatin Sodium
16729-010-17 Pravastatin Sodium
16729-011-15 Pravastatin Sodium
16729-011-16 Pravastatin Sodium
16729-011-17 Pravastatin Sodium

Recall Number: D-0381-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
65,233 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Daptomycin for Injection 350 mg/vial, Rx only, Packaged as: a) Single-dose vial NDC 16729-434-05 UPC 3 16729 43405 8; b) 10 Single-dose vials NDC 16729-434-45 UPC 3 16729 43445 4 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

Batch or Lot Expiration Information

Batch# Batches: a) R2101274, Exp. Date 9/30/2023; R2200161, Exp. Date 1/31/2025; R2200506, Exp. Date 1/31/2025; R2200697, Exp. Date 4/30/2025; R2201107, Exp. Date 7/31/2025; b) R2101471, Exp. Date 9/30/2023; R2200588, Exp. Date 4/30/2025; R2201333, Exp. Date 7/31/2025; R2201361, Exp. Date 8/31/2025

Affected Packages Involved in this Recall

16729-434-05 Daptomycin
16729-434-45 Daptomycin

Recall Number: D-0408-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
256,648 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Simvastatin Tablets USP 5 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-156-15, UPC 3 16729 15615 8; b) 1,000-count bottle NDC 16729-156-17, UPC 3 16729 15617 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

Batch or Lot Expiration Information

Batch# Batches: a) R2100818, Exp. Date 6/30/2023; R2100964, Exp. Date 6/30/2023; R2100824, Exp. Date 6/30/2023; R2100820, Exp. Date 6/30/2023; R2100822, Exp. Date 6/30/2023; R2101201, Exp. Date 9/30/2023; R2101198, Exp. Date 9/30/2023; R2101199, Exp. Date 9/30/2023; R2101200, Exp. Date 9/30/2023; R2101355, Exp. Date 10/31/2023; R2200035, Exp. Date 10/31/2023; R2200515, Exp. Date 4/30/2025; R2200514, Exp. Date 4/30/2025; R2200516, Exp. Date 4/30/2025; b) R2200310, Exp Date 9/30/2023; R2101354, Exp. Date 10/31/2023; R2200513, Exp. Date 4/30/2025; R2200768, Exp. Date 5/31/2025

Affected Packages Involved in this Recall

16729-005-10 Simvastatin
16729-005-12 Simvastatin
16729-005-15 Simvastatin
16729-005-17 Simvastatin
16729-006-10 Simvastatin
16729-006-12 Simvastatin
16729-006-15 Simvastatin
16729-006-17 Simvastatin
16729-007-10 Simvastatin
16729-007-12 Simvastatin
16729-007-15 Simvastatin
16729-007-17 Simvastatin
16729-156-10 Simvastatin
16729-156-15 Simvastatin
16729-156-17 Simvastatin
16729-004-10 Simvastatin
16729-004-12 Simvastatin
16729-004-15 Simvastatin
16729-004-17 Simvastatin

Recall Number: D-0407-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
102,360 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Rosuvastatin Tablets, USP 40 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-287-10, UPC 3 16729 28710 4; b) 90-count bottle NDC 16729-287-15, UPC 3 16729 28715 9; c) 1,000-count bottle NDC 16729-287-17, UPC 3 16729 28717 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

Batch or Lot Expiration Information

Batch# Batches: a) P2100343, Exp. Date 12/31/2023; P2102371, Exp. Date 3/31/2024; b) P2101966, Exp. Date 2/28/2024; P2104545, Exp. Date 6/30/2024; P2204500, Exp. Date 7/31/2025; P2205415, Exp. Date 8/31/2025; c) P2101591, Exp. Date 2/28/2023; P2200062, Exp. Date 12/31/2024; P2204336, Exp. Date 7/31/2025; P2204337, Exp. Date 7/31/2025; P2205416, Exp. Date 8/31/2025

Affected Packages Involved in this Recall

16729-284-10 Rosuvastatin
16729-284-15 Rosuvastatin
16729-284-17 Rosuvastatin
16729-285-10 Rosuvastatin
16729-285-15 Rosuvastatin
16729-285-17 Rosuvastatin
16729-286-10 Rosuvastatin
16729-286-15 Rosuvastatin
16729-286-17 Rosuvastatin
16729-287-10 Rosuvastatin
16729-287-15 Rosuvastatin
16729-287-17 Rosuvastatin

Recall Number: D-0395-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
1,158,839 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-003-01 UPC 3 16729 00301 8; b) 500-count NDC 16729-003-16 UPC 3 16729 00316 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

Batch or Lot Expiration Information

Batch# Batches: a) P2001868, Exp. Date 3/31/2023, P2001869 Exp. Date 3/31/2023, P2002810 Exp. Date 5/31/2023, P2005473 Exp. Date 8/31/2023, P2005552 Exp. Date 9/30/2023, P2101986 Exp. Date 3/31/2024, P2101989 Exp. Date 3/31/2024, P2101988 Exp. Date 3/31/2024, P2101991 Exp. Date 3/31/2024, P2101992 Exp. Date 3/31/2024, R2100736 Exp. Date 6/30/2024, R2100737 Exp. Date 6/30/2024, P2105281 Exp. Date 7/31/2024, R2101441 Exp. Date 9/30/2024, R2101454 Exp. Date 10/31/2024, R2101455 Exp. Date 10/31/2024, R2101468 Exp. Date 10/31/2024, R2101469 Exp. Date 10/31/2024, R2200096 Exp. Date 12/31/2024; b)P2005550, Exp. Date 9/30/2023, P2005549 Exp. Date 9/30/2023, P2005551 Exp. Date 9/30/2023, P2005812 Exp. Date 10/31/2023, P2005813 Exp. Date 10/31/2023, P2005970 Exp. Date 10/31/2023, P2005971 Exp. Date 10/31/2023, P2005974 Exp. Date 10/31/2023, P2005814 Exp. Date 10/31/2023, P2005972 Exp. Date 10/31/2023, P2005973 Exp. Date 10/31/2023, P2005998 Exp. Date 10/31/2023, P2005999 Exp. Date 10/31/2023, P2006001 Exp. Date 10/31/2023, P2005997 Exp. Date 10/31/2023, P2006000 Exp. Date 10/31/2023, P2100701 Exp. Date 1/31/2024, P2100702 Exp. Date 1/31/2024, P2100703 Exp. Date 1/31/2024, P2100704 Exp. Date 1/31/2024, P2102512 Exp. Date 3/31/2024, P2101993 Exp. Date 3/31/2024, P2101994 Exp. Date 3/31/2024, P2102951 Exp. Date 4/30/2024, P2102952 Exp. Date 4/30/2024, P2102953 Exp. Date 4/30/2024, P2102954 Exp. Date 4/30/2024, R2100739 Exp. Date 6/30/2024, R2100738 Exp. Date 6/30/2024, R2100740 Exp. Date 6/30/2024, P2104668 Exp. Date 6/30/2024, P2104669 Exp. Date 6/30/2024, P2104670 Exp. Date 6/30/2024, P2105283 Exp. Date 7/31/2024, P2105291 Exp. Date 7/31/2024, P2105282 Exp. Date 7/31/2024, P2105794 Exp. Date 7/31/2024, P2105292 Exp. Date 7/31/2024, P2105297 Exp. Date 7/31/2024, P2105293 Exp. Date 7/31/2024, P2105295 Exp. Date 7/31/2024, P2105294 Exp. Date 7/31/2024, R2101408 Exp. Date 9/30/2024, R2101409 Exp. Date 9/30/2024, R2101410 Exp. Date 9/30/2024, R2101411 Exp. Date 9/30/2024, R2101412 Exp. Date 9/30/2024, R2101413 Exp. Date 9/30/2024, R2200089 Exp. Date 12/31/2024, R2200097 Exp. Date 12/31/2024, R2200100 Exp. Date 12/31/2024, R2200101 Exp. Date 12/31/2024, R2200088 Exp. Date 12/31/2024, P2200775 Exp. Date 1/31/2025, P2200776 Exp. Date 1/31/2025, P2201221 Exp. Date 1/31/2025, P2201347 Exp. Date 2/28/2025, P2201348 Exp. Date 2/28/2025, R2200481 Exp. Date 3/31/2025, R2200576 Exp. Date 4/30/2025, P2203378 Exp. Date 5/31/2025, P2203379 Exp. Date 5/31/2025, P2203377 Exp. Date 5/31/2025, R2200966 Exp. Date 6/30/2025, R2200964 Exp. Date 6/30/2025, R2200973 Exp. Date 6/30/2025, P2204893 Exp. Date 8/31/2025

Affected Packages Involved in this Recall

16729-001-01 Glimepiride
16729-001-16 Glimepiride
16729-001-17 Glimepiride
16729-002-01 Glimepiride
16729-002-16 Glimepiride
16729-002-17 Glimepiride
16729-003-01 Glimepiride
16729-003-16 Glimepiride
16729-003-17 Glimepiride

Recall Number: D-0374-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
72,376 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 500 Tablets NDC 16729-047-16 UPC 3 16729 04716 6; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

Batch or Lot Expiration Information

Batch# Batches: a)R2100283, R2100288, R2100289, Exp. Date 2/28/2023; R2200235, Exp. Date 1/31/2024; R2201037, R2200952, Exp. Date 6/30/2024; b) R2100291, R2100281, R2100282, R2100292, R2100293, R2100294, R2100290, R2100306, R2100348, R2100349, R2100347, R2100350, R2100356, R2100355, Exp. Date 2/28/2023; R2100461, R2100463, R2100464, Exp. Date 3/31/2023; R2101214, R2101215, R2101216, Exp. Date 9/30/2023; R2101572, R2101573, R2101577, R2101578, R2101585, R2101579, R2101584, R2101587, R2101597, Exp. Date 11/30/2023; R2200801, Exp. Date 6/30/2024

Affected Packages Involved in this Recall

16729-045-10 Atorvastatin Calcium
16729-045-15 Atorvastatin Calcium
16729-045-01 Atorvastatin Calcium
16729-045-16 Atorvastatin Calcium
16729-045-17 Atorvastatin Calcium
16729-044-10 Atorvastatin Calcium
16729-044-15 Atorvastatin Calcium
16729-044-01 Atorvastatin Calcium
16729-044-16 Atorvastatin Calcium
16729-044-17 Atorvastatin Calcium
16729-046-10 Atorvastatin Calcium
16729-046-15 Atorvastatin Calcium
16729-046-01 Atorvastatin Calcium
16729-046-16 Atorvastatin Calcium
16729-046-17 Atorvastatin Calcium
16729-047-10 Atorvastatin Calcium
16729-047-15 Atorvastatin Calcium
16729-047-01 Atorvastatin Calcium
16729-047-16 Atorvastatin Calcium
16729-047-17 Atorvastatin Calcium

Recall Number: D-0376-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
24,408 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC 16729-200-01 UPC 3 16729 20001 1; b) 500 Tablets NDC 16729-200-16 UPC 3 16729 20016 5; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

Batch or Lot Expiration Information

Batch# Batches: a) P2200530, Exp. Date 12/31/2024; b) P2105583, Exp. Date 6/30/2024

Affected Packages Involved in this Recall

16729-203-12 Buspirone Hydrochloride
16729-203-01 Buspirone Hydrochloride
16729-203-59 Buspirone Hydrochloride
16729-203-16 Buspirone Hydrochloride
16729-203-17 Buspirone Hydrochloride
16729-289-12 Buspirone Hydrochloride
16729-289-01 Buspirone Hydrochloride
16729-289-59 Buspirone Hydrochloride
16729-289-16 Buspirone Hydrochloride
16729-289-17 Buspirone Hydrochloride
16729-200-01 Buspirone Hydrochloride
16729-200-16 Buspirone Hydrochloride
16729-200-17 Buspirone Hydrochloride
16729-201-01 Buspirone Hydrochloride
16729-201-16 Buspirone Hydrochloride
16729-201-17 Buspirone Hydrochloride
16729-202-01 Buspirone Hydrochloride
16729-202-16 Buspirone Hydrochloride
16729-202-17 Buspirone Hydrochloride

Recall Number: D-0410-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
1,394,208 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Simvastatin Tablets USP 20 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-005-15, UPC 3 16729 00515 9; b) 1,000-count bottle NDC 16729-005-17, UPC 3 16729 00517 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

Batch or Lot Expiration Information

Batch# Batches: a) P2102261, P2102284, P2102319, Exp. Date 3/31/2023, P2103536, Exp. Date 5/31/2023, P2104344, P2104342, P2104355, P2104356, P2104296, P2104380, Exp. Date 6/30/2023, R2200238, R2200239, Exp. Date 1/31/2024, R2200383, Exp. Date 2/28/2025; b) R2000554, R2000553, Exp. Date 9/30/2023; P2100562, P2100563,Exp. Date 12/31/2023; P2100692, P2100693, P2100722, P2100761, P2100762, P2101225, P2101200, P2101148, P2101149, P2101276, P2101345, Exp. Date 1/31/2024; P2101622, P2101664, P2101638, P2101785, P2101904, Exp. Date 2/29/2024; P2101951, P2101984, P2102367, P2102369, P2102368, P2102311, P2102316, P2102406, P2102455, Exp. Date 3/31/2024; P2102553, P2102554, P2102635, P2103233, P2103253, Exp. Date 4/30/2024; P2103360, P2103322, P2103414, P2103444, P2103415, P2103447, P2103573, P2103594, P2103615, P2103679, P2103648, P2103691, P2103646, P2103629, P2103704, P2103731, P2103763, P2103788, P2103789, P2103766, P2103876, P2103959, P2103833, Exp. Date 5/31/2024; P2103992; P2104045, P2104002, P2104046, P2104381, P2104407, P2104389, P2104644, P2104409, P2104649, P2104673, P2104684, P2104743, P2104696, P2104695, P2104745, P2105154, R2100826, R2100819, R2100829, P2104697, P2104746, P2105194, R2100837, R2100830, R2100836, P2105196, P2105220, P2105195, P2105222, R2100851, R2100856, Exp. Date 6/30/2024; P2105879, P2105920, P2105937, P2105973, P2105940, P2105986, P2105997, P2106009, P2106001, P2106010, P2106159, P2106182, P2106168, P2106202, P2106203, P2106217, P2106233, P2106214, P2106245, Exp. Date 8/31/2024; P2106333, P2106327, P2106342, P2106374, P2106405, P2106416, P2106429, P2106423, P2106412, Exp. Date 9/30/2024; R2200377, R2200542, R2200543, Exp. Date 2/28/2025; P2202795, P2202420, P2202445, Exp. Date 3/31/2025; R2200598, R2200590, R2200596, R2200591, P2202817, P2203290, P2202818, P2202819, Exp. Date 4/30/2025; P2203050, P2203006, P2203051, Exp. Date 5/31/2025

Affected Packages Involved in this Recall

16729-005-10 Simvastatin
16729-005-12 Simvastatin
16729-005-15 Simvastatin
16729-005-17 Simvastatin
16729-006-10 Simvastatin
16729-006-12 Simvastatin
16729-006-15 Simvastatin
16729-006-17 Simvastatin
16729-007-10 Simvastatin
16729-007-12 Simvastatin
16729-007-15 Simvastatin
16729-007-17 Simvastatin
16729-156-10 Simvastatin
16729-156-15 Simvastatin
16729-156-17 Simvastatin
16729-004-10 Simvastatin
16729-004-12 Simvastatin
16729-004-15 Simvastatin
16729-004-17 Simvastatin

Recall Number: D-0399-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
322 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial, 10vial carton, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 20mL vial NDC 16729-474-05 UPC 3 16729 47405 4;carton NDC 16729-474-03 UPC 3 16729 47403 0

Batch or Lot Expiration Information

Batch# Batches: R2200431, Exp. Date 7/31/2023, R2200439, Exp. Date 9/30/2023

Affected Packages Involved in this Recall

16729-471-08 Glycopyrrolate
16729-472-08 Glycopyrrolate
16729-473-03 Glycopyrrolate
16729-474-03 Glycopyrrolate
16729-474-05 Glycopyrrolate

Recall Number: D-0365-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
747,464 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Aripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC 16729-278-10, UPC 3 16729 27810 2; b) 100-count bottle, NDC 16729-278-01, UPC 3 16729 27801 10 Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India

Batch or Lot Expiration Information

Batch# Batches: a) P2005474, Exp 9/30/2023; P2100001, Exp 12/31/2023; P2100789, P2100790, Exp 1/31/2024; P2101319, Exp 2/28/2024; P2102147, P2102148, Exp 3/31/2024; P2104084, Exp 6/30/2024; P2105410, P2107233, P2105411, Exp 7/31/2024; P2106671, P2106673, P2106675, Exp 9/30/2024; P2200428, P2200429, P2200430, Exp 12/31/2024; P2203333, P2203334, Exp 5/31/2025; b) P2102940 Exp. 3/31/2023, P2105793, Exp. 7/31/2024

Affected Packages Involved in this Recall

16729-278-10 Aripiprazole
16729-278-01 Aripiprazole
16729-278-16 Aripiprazole
16729-278-46 Aripiprazole
16729-279-10 Aripiprazole
16729-279-01 Aripiprazole
16729-279-16 Aripiprazole
16729-279-46 Aripiprazole
16729-280-10 Aripiprazole
16729-280-01 Aripiprazole
16729-280-16 Aripiprazole
16729-280-46 Aripiprazole
16729-281-10 Aripiprazole
16729-281-01 Aripiprazole
16729-281-16 Aripiprazole
16729-281-46 Aripiprazole
16729-282-10 Aripiprazole
16729-282-01 Aripiprazole
16729-282-16 Aripiprazole
16729-282-46 Aripiprazole
16729-283-10 Aripiprazole
16729-283-01 Aripiprazole
16729-283-16 Aripiprazole
16729-283-46 Aripiprazole

Recall Number: D-0405-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
56,862 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Rosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-285-15, UPC 3 16729 28515 5; b) 1,000-count bottle NDC 16729-285-17, UPC 3 16729 28517 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

Batch or Lot Expiration Information

Batch# Batches: a) P2006824, Exp. Date 11/30/2023; P2102223, Exp. Date 3/31/2024; b) P2004949, Exp. Date 8/31/2023; P2004948, Exp. Date 8/31/2023; P2004950, Exp. Date 8/31/2023; P2004953, Exp. Date 8/31/2023; P2004954, Exp. Date 8/31/2023; P2004956, Exp. Date 8/31/2023; P2004955, Exp. Date 8/31/2023; P2004957, Exp. Date 8/31/2023; P2004958, Exp. Date 8/31/2023; P2004959, Exp. Date 8/31/2023; P2005252, Exp. Date 9/30/2023; P2006607, Exp. Date 11/30/2023; P2101368, Exp. Date 2/29/2024; P2101777, Exp. Date 2/29/2024; P2102224, Exp. Date 3/31/2024; P2104397, Exp. Date 6/30/2024; P2104395, Exp. Date 6/30/2024; P2104398, Exp. Date 6/30/2024; P2105120, Exp. Date 7/31/2024; P2204835, Exp. Date 7/31/2025; P2204834, Exp. Date 7/31/2025; P2204837, Exp. Date 7/31/2025; P2205832, Exp. Date 9/30/2025; P2205833, Exp. Date 9/30/2025

Affected Packages Involved in this Recall

16729-284-10 Rosuvastatin
16729-284-15 Rosuvastatin
16729-284-17 Rosuvastatin
16729-285-10 Rosuvastatin
16729-285-15 Rosuvastatin
16729-285-17 Rosuvastatin
16729-286-10 Rosuvastatin
16729-286-15 Rosuvastatin
16729-286-17 Rosuvastatin
16729-287-10 Rosuvastatin
16729-287-15 Rosuvastatin
16729-287-17 Rosuvastatin

Recall Number: D-0416-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
176,323 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10, UPC 3 16729 37110 0; b) 500-count bottle NDC 16729-371-16, UPC 3 16729 37116 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

Batch or Lot Expiration Information

Batch# Batches: a) P2002525, Exp. Date 4/30/2023; P2004442, Exp. Date 7/31/2023; P2005014, Exp. Date 8/31/2023; P2005015, Exp. Date 8/31/2023; P2005016, Exp. Date 8/31/2023; P2005825, Exp. Date 10/31/2023; P2005824, Exp. Date 10/31/2023; P2005826, Exp. Date 10/31/2023; P2100368, Exp. Date 12/31/2023; P2100444, Exp. Date 12/31/2023; P2101262, Exp. Date 2/29/2024; P2101263, Exp. Date 2/29/2024; P2200813, Exp. Date 1/31/2025; P2200814, Exp. Date 1/31/2025; b) P2002526, Exp. Date 4/30/2023; P2003781, Exp. Date 6/30/2023; P2003782, Exp. Date 6/30/2023; P2003783, Exp. Date 6/30/2023; P2004440, Exp. Date 7/31/2023; P2004441, Exp. Date 7/31/2023; P2005820, Exp. Date 10/31/2023; P2005821, Exp. Date 10/31/2023; P2005823, Exp. Date 10/31/2023; P2100077, Exp. Date 12/31/2023; P2100076, Exp. Date 12/31/2023; P2100078, Exp. Date 12/31/2023; P2100079, Exp. Date 12/31/2023; P2100080, Exp. Date 12/31/2023; P2100366, Exp. Date 12/31/2023; P2100442, Exp. Date 12/31/2023; P2100443, Exp. Date 12/31/2023; P2101265, Exp. Date 2/29/2024; P2101264, Exp. Date 2/29/2024; P2101718, Exp. Date 2/29/2024; P2108091, Exp. Date 11/30/2024; P2108092, Exp. Date 11/30/2024; P2108093, Exp. Date 11/30/2024; P2203589, Exp. Date 6/30/2025; P2203588, Exp. Date 6/30/2025; P2205379, Exp. Date 8/31/2025

Affected Packages Involved in this Recall

16729-370-10 Tadalafil
16729-370-15 Tadalafil
16729-370-16 Tadalafil
16729-370-17 Tadalafil
16729-370-97 Tadalafil
16729-369-10 Tadalafil
16729-369-15 Tadalafil
16729-369-16 Tadalafil
16729-369-17 Tadalafil
16729-369-97 Tadalafil
16729-371-10 Tadalafil
16729-371-15 Tadalafil
16729-371-16 Tadalafil
16729-371-17 Tadalafil
16729-372-10 Tadalafil
16729-372-15 Tadalafil
16729-372-16 Tadalafil
16729-372-17 Tadalafil

Recall Number: D-0372-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
241,585 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-045-15 UPC 3 16729 04515 5; b) 1,000 Tablets NDC 16729-045-17 UPC 3 16729 04517 9, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

Batch or Lot Expiration Information

Batch# Batches: a)R2100305, Exp. Date 2/28/2023; R2200227, Exp. Date 1/31/2024; R2200797, Exp. Date 6/30/2024; b) R2101423, R2101438, R2101447, R2101446, Exp. Date 10/31/2023; R2200040, R2200041, R2200052, R2200043, R2200044, R2200051, R2200060, R2200061, R2200062, R2200077, R2200078, Exp. Date 12/31/2023; R2200228, R2200480, Exp. Date 1/31/2024; R2200266, R2200267, R2200265, R2200268, Exp. Date 2/29/2024; R2200370, Exp. Date 3/31/2024; R2201038, Exp. Date 6/30/2024

Affected Packages Involved in this Recall

16729-045-10 Atorvastatin Calcium
16729-045-15 Atorvastatin Calcium
16729-045-01 Atorvastatin Calcium
16729-045-16 Atorvastatin Calcium
16729-045-17 Atorvastatin Calcium
16729-044-10 Atorvastatin Calcium
16729-044-15 Atorvastatin Calcium
16729-044-01 Atorvastatin Calcium
16729-044-16 Atorvastatin Calcium
16729-044-17 Atorvastatin Calcium
16729-046-10 Atorvastatin Calcium
16729-046-15 Atorvastatin Calcium
16729-046-01 Atorvastatin Calcium
16729-046-16 Atorvastatin Calcium
16729-046-17 Atorvastatin Calcium
16729-047-10 Atorvastatin Calcium
16729-047-15 Atorvastatin Calcium
16729-047-01 Atorvastatin Calcium
16729-047-16 Atorvastatin Calcium
16729-047-17 Atorvastatin Calcium

Recall Number: D-0397-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
5,273 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Glycopyrrolate Injection, USP, 0.4 mg/2 mL (0.2 mg/mL) 2 mL Single Dose Vial X 25 vials carton, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA 2 ML vial NDC 16729-472-30 UPC 3 16729 47230 2; carton NDC 16729-472-08 UPC 3 16729 47208 1

Batch or Lot Expiration Information

Batch# Batches: R2200509, Exp. Date 4/30/2024, R2200507, Exp. Date 4/30/2024, R2200508, Exp. Date 4/30/2024

Affected Packages Involved in this Recall

16729-471-08 Glycopyrrolate
16729-472-08 Glycopyrrolate
16729-473-03 Glycopyrrolate
16729-474-03 Glycopyrrolate
16729-474-05 Glycopyrrolate
16729-472-30 Glycopyrrolate

Recall Number: D-0366-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
1,109,904 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-279-10, UPC 3 16729 27910 9; b) 100-count bottle, NDC 16729-279-01, UPC 3 16729 27901 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India

Batch or Lot Expiration Information

Batch# Batches: a) P2004259, P2004260, P2004261, Exp. Date 7/31/2023; P2006799, P2101391, Exp. Date 11/30/2023; P2100826, Exp. Date 1/31/2024; P2101320, Exp. Date 2/28/2024; P2102510, P2102409, P2102407, Exp. Date 3/31/2024; P2102410, Exp. Date 3/31/2024; P2105251, P2105252, P2105253, Exp. Date 7/31/2024; P2107404, P2107029, Exp. Date 10/31/2024; P2200260, P2200265, Exp. Date 12/31/2024; P2202067, P2202068, Exp. Date 3/31/2025; P2204239, Exp. Date 7/31/2025; b) P2006800 Exp. Date 11/30/2023; P2102141, Exp. Date 3/31/2024; P2104085, Exp. Date 6/30/2024; P2107031, P2107466, Exp. Date 10/31/2024

Affected Packages Involved in this Recall

16729-278-10 Aripiprazole
16729-278-01 Aripiprazole
16729-278-16 Aripiprazole
16729-278-46 Aripiprazole
16729-279-10 Aripiprazole
16729-279-01 Aripiprazole
16729-279-16 Aripiprazole
16729-279-46 Aripiprazole
16729-280-10 Aripiprazole
16729-280-01 Aripiprazole
16729-280-16 Aripiprazole
16729-280-46 Aripiprazole
16729-281-10 Aripiprazole
16729-281-01 Aripiprazole
16729-281-16 Aripiprazole
16729-281-46 Aripiprazole
16729-282-10 Aripiprazole
16729-282-01 Aripiprazole
16729-282-16 Aripiprazole
16729-282-46 Aripiprazole
16729-283-10 Aripiprazole
16729-283-01 Aripiprazole
16729-283-16 Aripiprazole
16729-283-46 Aripiprazole

Recall Number: D-0367-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
539,004 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5; b) 100-count bottle, NDC 16729-280-01, UPC 3 16729 28001 3; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India

Batch or Lot Expiration Information

Batch# Batches: a)P2006421, P2004882, P2004939, P2004883, P2004940, P2004942, P2004943, P2004944, Exp. Date 8/31/2023; P2107593, P2106907, P2106906, P2106908, P2106909, Exp. Date 10/31/2024; b)P2102144, Exp. Date 3/31/2023; P2106903 Exp. Date 10/31/2023; P2204437, Exp. Date 7/31/2025

Affected Packages Involved in this Recall

16729-278-10 Aripiprazole
16729-278-01 Aripiprazole
16729-278-16 Aripiprazole
16729-278-46 Aripiprazole
16729-279-10 Aripiprazole
16729-279-01 Aripiprazole
16729-279-16 Aripiprazole
16729-279-46 Aripiprazole
16729-280-10 Aripiprazole
16729-280-01 Aripiprazole
16729-280-16 Aripiprazole
16729-280-46 Aripiprazole
16729-281-10 Aripiprazole
16729-281-01 Aripiprazole
16729-281-16 Aripiprazole
16729-281-46 Aripiprazole
16729-282-10 Aripiprazole
16729-282-01 Aripiprazole
16729-282-16 Aripiprazole
16729-282-46 Aripiprazole
16729-283-10 Aripiprazole
16729-283-01 Aripiprazole
16729-283-16 Aripiprazole
16729-283-46 Aripiprazole

Recall Number: D-0421-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
9600 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729 00815 0; b) 500-count bottle NDC 16729-008-16, UPC 3 16729 00816 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

Batch or Lot Expiration Information

Batch# Batches: a) R2201093, Exp. Date 4/30/2024; b) R2201222, R2201231, Exp. Date 4/30/2024

Affected Packages Involved in this Recall

16729-008-15 Pravastatin Sodium
16729-008-16 Pravastatin Sodium
16729-008-17 Pravastatin Sodium
16729-009-15 Pravastatin Sodium
16729-009-16 Pravastatin Sodium
16729-009-17 Pravastatin Sodium
16729-010-15 Pravastatin Sodium
16729-010-16 Pravastatin Sodium
16729-010-17 Pravastatin Sodium
16729-011-15 Pravastatin Sodium
16729-011-16 Pravastatin Sodium
16729-011-17 Pravastatin Sodium

Recall Number: D-0409-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
291,378 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Simvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-004-15, UPC 3 16729 00415 2; b) 1,000-count bottle NDC 16729-004-17, UPC 3 16729 00417 6; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

Batch or Lot Expiration Information

Batch# Batches: a) P2106923, Exp. Date 9/30/2023; R2101544, Exp. Date 10/31/2023; R2200732, Exp. Date 5/31/2025; b) P2101634, Exp. Date 2/28/2023; P2102370, Exp. Date 3/31/2023; P2102321, Exp. Date 3/31/2023; P2102411, Exp. Date 3/31/2023; P2102454, Exp. Date 3/31/2023; P2103991, Exp. Date 5/31/2023; R2100954, Exp. Date 6/30/2023; R2100947, Exp. Date 6/30/2023; R2100951, Exp. Date 6/30/2023; P2106242, Exp. Date 8/31/2023; P2106928, Exp. Date 9/30/2023; P2107424, Exp. Date 9/30/2023; R2101542, Exp. Date 10/31/2023; R2101543, Exp. Date 10/31/2023; R2200026, Exp. Date 11/30/2023; R2200414, Exp. Date 2/29/2024; R2200416, Exp. Date 2/28/2025; R2200586, Exp. Date 4/30/2025; R2200679, Exp. Date 5/31/2025; R2200824, Exp. Date 5/31/2025

Affected Packages Involved in this Recall

16729-005-10 Simvastatin
16729-005-12 Simvastatin
16729-005-15 Simvastatin
16729-005-17 Simvastatin
16729-006-10 Simvastatin
16729-006-12 Simvastatin
16729-006-15 Simvastatin
16729-006-17 Simvastatin
16729-007-10 Simvastatin
16729-007-12 Simvastatin
16729-007-15 Simvastatin
16729-007-17 Simvastatin
16729-156-10 Simvastatin
16729-156-15 Simvastatin
16729-156-17 Simvastatin
16729-004-10 Simvastatin
16729-004-12 Simvastatin
16729-004-15 Simvastatin
16729-004-17 Simvastatin

Recall Number: D-0383-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
37,790 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-490-12 UPC 3 16729 49012 2

Batch or Lot Expiration Information

Batch# Batches: P2101480, Exp. Date 2/28/2023; P2102579, P2102596, Exp. Date 4/30/2023; P2104711, P2104707, Exp. Date 6/30/2023; P2200771, P2200829, P2200795, Exp. Date 12/31/2023; P2202608, Exp. Date 4/30/2025; P2203492, P2203463, Exp. Date 5/31/2025; P2205373, P2205412, Exp. Date 8/31/2025

Affected Packages Involved in this Recall

16729-490-12 Dofetilide
16729-490-59 Dofetilide
16729-491-12 Dofetilide
16729-491-59 Dofetilide
16729-492-12 Dofetilide
16729-492-59 Dofetilide

Recall Number: D-0422-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
32,688 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. NDC 16729-009-15, UPC 3 16729 00915 7.

Batch or Lot Expiration Information

Batch# Batches: a )R2200589, R2200689, R2200690, R2201232, Exp. Date 4/30/2024

Affected Packages Involved in this Recall

16729-008-15 Pravastatin Sodium
16729-008-16 Pravastatin Sodium
16729-008-17 Pravastatin Sodium
16729-009-15 Pravastatin Sodium
16729-009-16 Pravastatin Sodium
16729-009-17 Pravastatin Sodium
16729-010-15 Pravastatin Sodium
16729-010-16 Pravastatin Sodium
16729-010-17 Pravastatin Sodium
16729-011-15 Pravastatin Sodium
16729-011-16 Pravastatin Sodium
16729-011-17 Pravastatin Sodium

Recall Number: D-0379-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
25,812 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA, NDC 16729-289-12 UPC 3 16729 28912 2

Batch or Lot Expiration Information

Batch# Batches: P2105551, Exp. Date 7/31/2024

Affected Packages Involved in this Recall

16729-203-12 Buspirone Hydrochloride
16729-203-01 Buspirone Hydrochloride
16729-203-59 Buspirone Hydrochloride
16729-203-16 Buspirone Hydrochloride
16729-203-17 Buspirone Hydrochloride
16729-289-12 Buspirone Hydrochloride
16729-289-01 Buspirone Hydrochloride
16729-289-59 Buspirone Hydrochloride
16729-289-16 Buspirone Hydrochloride
16729-289-17 Buspirone Hydrochloride
16729-200-01 Buspirone Hydrochloride
16729-200-16 Buspirone Hydrochloride
16729-200-17 Buspirone Hydrochloride
16729-201-01 Buspirone Hydrochloride
16729-201-16 Buspirone Hydrochloride
16729-201-17 Buspirone Hydrochloride
16729-202-01 Buspirone Hydrochloride
16729-202-16 Buspirone Hydrochloride
16729-202-17 Buspirone Hydrochloride

Recall Number: D-0368-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
312,864 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 16729 28110 2; b) 100-count bottle NDC 16729-281-01, UPC 3 16729 28101 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India

Batch or Lot Expiration Information

Batch# Batches: a) P2004997, P2004998, P2004999, Exp. Date 8/31/2023; P2101206, Exp. Date 1/31/2024 , P2102486, Exp. Date 4/30/2024; P2106247, P2105375, Exp. Date 7/31/2024; P2107239, P2107240, Exp. Date 10/31/2024; b) P2204222 Exp. Date 7/31/2025, P2105374 Exp. 7/31/2024, P2203449 Exp. 5/31/2025

Affected Packages Involved in this Recall

16729-278-10 Aripiprazole
16729-278-01 Aripiprazole
16729-278-16 Aripiprazole
16729-278-46 Aripiprazole
16729-279-10 Aripiprazole
16729-279-01 Aripiprazole
16729-279-16 Aripiprazole
16729-279-46 Aripiprazole
16729-280-10 Aripiprazole
16729-280-01 Aripiprazole
16729-280-16 Aripiprazole
16729-280-46 Aripiprazole
16729-281-10 Aripiprazole
16729-281-01 Aripiprazole
16729-281-16 Aripiprazole
16729-281-46 Aripiprazole
16729-282-10 Aripiprazole
16729-282-01 Aripiprazole
16729-282-16 Aripiprazole
16729-282-46 Aripiprazole
16729-283-10 Aripiprazole
16729-283-01 Aripiprazole
16729-283-16 Aripiprazole
16729-283-46 Aripiprazole

Recall Number: D-0411-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
1,190,484 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15, UPC 3 16729 00615 6; b) 1,000-count tablets NDC 16729-006-17, UPC 3 16729 00617 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

Batch or Lot Expiration Information

Batch# Batches: a) P2103713, P2103692, Exp. Date 5/31/2023, P2104950, P2104984, P2104969, P2104996, P2105274, P2105314, P2105316, Exp. Date 7/31/2023, R2101074, R2101077, R2101078, R2101079, R2101083, R2101084, R2101117, Exp. Date 8/31/2023, R2101330, R2101331, R2101335, R2101336, R2101334, R2101337, R2101339, Exp. Date 9/30/2023, R2101494, R2101495, R2101496, R2101497, Exp. Date 10/31/2023, R2200527, R2200531, Exp. Date 3/31/2024, R2200606, R2200625, Exp. Date 4/30/2024; b) P2101911, P2101913, R2100344, R2100351, R2100354, R2100346, R2100357, R2100358, R2100359, R2100361, R2100362, R2100385, R2100386, R2100388, R2100394, R2100397, R2100345, Exp. Date 2/28/2023; P2101930, P2101983, R2100435, R2100457, R2100433, R2100462, R2100466, R2100465, R2100469, R2100468, Exp. Date 3/31/2023; P2103223, P2103229, P2103234, Exp. Date 4/30/2023; P2103254, P2103258, P2103261, P2103323, P2103362, P2103364, P2103310, P2103671, P2103678, P2103545, P2103568, P2103599, P2103616, P2103627, P2103649, P2103813, P2103832, P2103834, P2103867, P2103868, P2103901, P2103912, Exp. Date 5/31/2023; P2105024, P2105027, P2105028, P2105049, P2105047, P2105052, P2105340, P2105341, P2105420, P2105432, P2105445, P2105455, P2105456, P2105467, P2105461, Exp. Date 7/31/2024; R2101118, R2101119, R2101127, R2101128, R2101134, R2101145, R2101133, R2101146, R2101149, R2101164, R2101169, R2101165, R2101187, R2101188, R2101192, R2101193, R2101168, R2101194, Exp. Date 8/31/2024; R2101516, R2101517, R2101515, R2101523, R2101525, R2101524, R2101530, R2101531, R2101532, R2101534, R2101533, R2101541, R2101547, R2101569, R2101567, R2101568, R2101571, R2101580, R2101582, R2101592, R2101583, R2101581, R2101593, P2107446, Exp. Date 10/31/2024; P2107791, P2107792, Exp. Date 11/30/2024; R2200271, R2200272, R2200275, Exp. Date 1/31/2025; R2200374, R2200379, R2200378, R2200391, Exp. Date 2/28/2025; R2200457, R2200458, R2200540, R2200470, R2200541, R2200459, R2200451, R2200471, Exp. Date 3/31/2025; R2200610, R2200611, R2200616, R2200615,R2200624, R2200628, R2200736, Exp. Date 4/30/2025, R2200688, R2200681, R2200687, Exp. Date 5/31/2025

Affected Packages Involved in this Recall

16729-005-10 Simvastatin
16729-005-12 Simvastatin
16729-005-15 Simvastatin
16729-005-17 Simvastatin
16729-006-10 Simvastatin
16729-006-12 Simvastatin
16729-006-15 Simvastatin
16729-006-17 Simvastatin
16729-007-10 Simvastatin
16729-007-12 Simvastatin
16729-007-15 Simvastatin
16729-007-17 Simvastatin
16729-156-10 Simvastatin
16729-156-15 Simvastatin
16729-156-17 Simvastatin
16729-004-10 Simvastatin
16729-004-12 Simvastatin
16729-004-15 Simvastatin
16729-004-17 Simvastatin

Recall Number: D-0369-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
170,448 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3 16729 28210 9; b) 100-count bottle, NDC 16729-282-01, UPC 3 16729 28201 7; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India

Batch or Lot Expiration Information

Batch# Batches: a) P2100787, P2100788, Exp. Date 1/31/2024; P2104736, Exp. Date 6/30/2024; P2105492, Exp. Date 8/31/2024; P2107172, P2107175, Exp. Date 10/31/2024; P2203043, Exp. Date 5/31/2025; b) P2104086 Exp. Date 6/30/2024, P2205370 Exp. 8/31/2025

Affected Packages Involved in this Recall

16729-278-10 Aripiprazole
16729-278-01 Aripiprazole
16729-278-16 Aripiprazole
16729-278-46 Aripiprazole
16729-279-10 Aripiprazole
16729-279-01 Aripiprazole
16729-279-16 Aripiprazole
16729-279-46 Aripiprazole
16729-280-10 Aripiprazole
16729-280-01 Aripiprazole
16729-280-16 Aripiprazole
16729-280-46 Aripiprazole
16729-281-10 Aripiprazole
16729-281-01 Aripiprazole
16729-281-16 Aripiprazole
16729-281-46 Aripiprazole
16729-282-10 Aripiprazole
16729-282-01 Aripiprazole
16729-282-16 Aripiprazole
16729-282-46 Aripiprazole
16729-283-10 Aripiprazole
16729-283-01 Aripiprazole
16729-283-16 Aripiprazole
16729-283-46 Aripiprazole

Recall Number: D-0419-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
2614 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. Bottle NDC 16729-467-15, UPC 3 16729 46715 5; Carton NDC 16729-467-85, UPC 3 16729 46785 8.

Batch or Lot Expiration Information

Batch# Batches: P2202518, P2202512, Exp. Date 4/30/2024, P2204588, P2204589, Exp. Date 7/31/2024

Affected Packages Involved in this Recall

16729-468-15 Pirfenidone
16729-468-64 Pirfenidone
16729-467-15 Pirfenidone
16729-467-85 Pirfenidone
16729-467-64 Pirfenidone

Recall Number: D-0414-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
36,773 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7; b) 500-count bottle NDC 16729-369-16, UPC 3 16729 36916 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

Batch or Lot Expiration Information

Batch# Batches: a) P2002522, Exp. Date 4/30/2023; P2005817, P2005816, Exp. Date 10/31/2023; P2203687, Exp. Date 6/30/2025; b) P2002521, Exp. Date 4/30/2023; P2005818, Exp. Date 10/31/2023; P2100075, Exp. Date 12/31/2023; P2100996, P2100997, P2100998, P2100999, Exp. Date 1/31/2024

Affected Packages Involved in this Recall

16729-370-10 Tadalafil
16729-370-15 Tadalafil
16729-370-16 Tadalafil
16729-370-17 Tadalafil
16729-370-97 Tadalafil
16729-369-10 Tadalafil
16729-369-15 Tadalafil
16729-369-16 Tadalafil
16729-369-17 Tadalafil
16729-369-97 Tadalafil
16729-371-10 Tadalafil
16729-371-15 Tadalafil
16729-371-16 Tadalafil
16729-371-17 Tadalafil
16729-372-10 Tadalafil
16729-372-15 Tadalafil
16729-372-16 Tadalafil
16729-372-17 Tadalafil

Recall Number: D-0417-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
613,553 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7; b) 500-count bottle NDC 16729-372-16, UPC 3 16729 37216 9; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

Batch or Lot Expiration Information

Batch# Batches: a) P2002461, Exp. Date 4/30/2023; P2002457, Exp. Date 4/30/2023; P2002460, Exp. Date 4/30/2023; P2002464, Exp. Date 4/30/2023; P2002463, Exp. Date 4/30/2023; P2002462, Exp. Date 4/30/2023; P2002465, Exp. Date 4/30/2023; P2003153, Exp. Date 5/31/2023; P2003155, Exp. Date 5/31/2023; P2003156, Exp. Date 5/31/2023; P2003154, Exp. Date 5/31/2023; P2003152, Exp. Date 5/31/2023; P2003157, Exp. Date 5/31/2023; P2003158, Exp. Date 5/31/2023; P2003159, Exp. Date 5/31/2023; P2003162, Exp. Date 5/31/2023; P2003160, Exp. Date 5/31/2023; P2003778, Exp. Date 6/30/2023; P2003779, Exp. Date 6/30/2023; P2004315, Exp. Date 6/30/2023; P2004818, Exp. Date 8/31/2023; P2004819, Exp. Date 8/31/2023; P2005158, Exp. Date 8/31/2023; P2005156, Exp. Date 8/31/2023; P2005157, Exp. Date 8/31/2023; P2005247, Exp. Date 9/30/2023; P2006641, Exp. Date 11/30/2023; P2101002, Exp. Date 1/31/2024; P2101004, Exp. Date 1/31/2024; P2101003, Exp. Date 1/31/2024; P2101006, Exp. Date 1/31/2024; P2101005, Exp. Date 1/31/2024; P2101008, Exp. Date 1/31/2024; P2101023, Exp. Date 1/31/2024; P2101022, Exp. Date 1/31/2024; P2101274, Exp. Date 2/29/2024; P2202085, Exp. Date 3/31/2025; b) P2002467, Exp. Date 4/30/2023; P2002466, Exp. Date 4/30/2023; P2002468, Exp. Date 4/30/2023; P2003780, Exp. Date 6/30/2023; P2005154, Exp. Date 8/31/2023; P2005244, Exp. Date 9/30/2023; P2005246, Exp. Date 9/30/2023; P2005809, Exp. Date 10/31/2023; P2005810, Exp. Date 10/31/2023; P2006642, Exp. Date 11/30/2023; P2006643, Exp. Date 11/30/2023; P2006644, Exp. Date 11/30/2023; P2006645, Exp. Date 11/30/2023; P2006646, Exp. Date 11/30/2023; P2006647, Exp. Date 11/30/2023; P2100463, Exp. Date 12/31/2023; P2100462, Exp. Date 12/31/2023; P2100464, Exp. Date 12/31/2023; P2100465, Exp. Date 12/31/2023; P2100498, Exp. Date 12/31/2023; P2100497, Exp. Date 12/31/2023; P2100499, Exp. Date 12/31/2023; P2100573 ,Exp. Date 1/31/2024; P2100572, Exp. Date 1/31/2024; P2100574, Exp. Date 1/31/2024; P2101007, Exp. Date 1/31/2024; P2202084, Exp. Date 3/31/2025

Affected Packages Involved in this Recall

16729-370-10 Tadalafil
16729-370-15 Tadalafil
16729-370-16 Tadalafil
16729-370-17 Tadalafil
16729-370-97 Tadalafil
16729-369-10 Tadalafil
16729-369-15 Tadalafil
16729-369-16 Tadalafil
16729-369-17 Tadalafil
16729-369-97 Tadalafil
16729-371-10 Tadalafil
16729-371-15 Tadalafil
16729-371-16 Tadalafil
16729-371-17 Tadalafil
16729-372-10 Tadalafil
16729-372-15 Tadalafil
16729-372-16 Tadalafil
16729-372-17 Tadalafil

Recall Number: D-0415-2023

Reason for Recall
CGMP Deviations: recalling drug products following an FDA inspection.
Initiated
02-07-2023
Reported
03-08-2023
Quantity
1,113,264 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91657
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Accord Healthcare, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
United States including Puerto Rico and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-22-2024
Product Description About Product Description
Full technical description of the product.
Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 16729 37010 3; b) 500-count bottle NDC 16729-370-16, UPC 3 16729 37016 5; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA

Batch or Lot Expiration Information

Batch# Batches: a) P2002450, Exp. Date 4/30/2023, P2003222, Exp. Date 5/31/2023; P2003223, Exp. Date 5/31/2023; P2003224, Exp. Date 5/31/2023; P2004636, Exp. Date 8/31/2023; P2005035, Exp. Date 8/31/2023; P2005038, Exp. Date 8/31/2023; P2005040, Exp. Date 8/31/2023; P2005039, Exp. Date 8/31/2023; P2005041, Exp. Date 8/31/2023; P2005606, Exp. Date 9/30/2023; P2100340, Exp. Date 9/30/2023; P2100009, Exp. Date 12/31/2023; P2100010, Exp. Date 12/31/2023; P2100044, Exp. Date 12/31/2023; P2100045, Exp. Date 12/31/2023; P2100046, Exp. Date 12/31/2023; P2101129, Exp. Date 1/31/2024; P2101880, Exp. Date 1/31/2024; P2101130, Exp. Date 1/31/2024; P2101131, Exp. Date 1/31/2024; P2106689, Exp. Date 9/30/2024; P2106691, Exp. Date 9/30/2024; P2203585, Exp. Date 6/30/2025; b) P2002451 Exp. Date 4/30/2023; P2005365, Exp. Date 8/31/2023; P2005036, Exp. Date 8/31/2023; P2005037, Exp. Date 8/31/2023; P2005607, Exp. Date 9/30/2023; P2005608, Exp. Date 9/30/2023; P2100048, Exp. Date 12/31/2023; P2100052, Exp. Date 12/31/2023; P2100053, Exp. Date 12/31/2023; P2100055, Exp. Date 12/31/2023; P2100054, Exp. Date 12/31/2023; P2100387, Exp. Date 12/31/2023; P2100526, Exp. Date 12/31/2023; P2100525, Exp. Date 12/31/2023; P2100528, Exp. Date 12/31/2023; P2100530, Exp. Date 12/31/2023; P2100532, Exp. Date 12/31/2023; P2100531, Exp. Date 12/31/2023; P2100533, Exp. Date 12/31/2023; P2101127, Exp. Date 1/31/2024; P2101128, Exp. Date 1/31/2024; P2106094, Exp. Date 8/31/2024; P2106091, Exp. Date 8/31/2024; P2106093, Exp. Date 8/31/2024; P2200039, Exp. Date 9/30/2024; P2107771, Exp. Date 11/30/2024; P2107774, Exp. Date 11/30/2024; P2107772, Exp. Date 11/30/2024; P2200505, Exp. Date 12/31/2024; P2200506, Exp. Date 12/31/2024; P2200503, Exp. Date 12/31/2024; P2200510, Exp. Date 12/31/2024; P2200508, Exp. Date12/31/2024; P2203056, Exp. Date 5/31/2025; P2203058, Exp. Date 5/31/2025; P2203060, Exp. Date 5/31/2025; P2203057, Exp. Date 5/31/2025; P2203059, Exp. Date 5/31/2025; P2203584, Exp. Date 6/30/2025; P2205372, Exp. Date 8/31/2025; P2205376, Exp. Date 8/31/2025

Affected Packages Involved in this Recall

16729-370-10 Tadalafil
16729-370-15 Tadalafil
16729-370-16 Tadalafil
16729-370-17 Tadalafil
16729-370-97 Tadalafil
16729-369-10 Tadalafil
16729-369-15 Tadalafil
16729-369-16 Tadalafil
16729-369-17 Tadalafil
16729-369-97 Tadalafil
16729-371-10 Tadalafil
16729-371-15 Tadalafil
16729-371-16 Tadalafil
16729-371-17 Tadalafil
16729-372-10 Tadalafil
16729-372-15 Tadalafil
16729-372-16 Tadalafil
16729-372-17 Tadalafil