Multi-event April 2015 FDA Recall Drug by Wockhardt Usa Inc.

This Multi-event Class II drug recall was voluntarily initiated by Wockhardt Usa Inc. on April 22, 2015 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1271-2015 TERMINATED D-1252-2015 TERMINATED D-1268-2015 TERMINATED D-1276-2015 TERMINATED D-1246-2015 TERMINATED D-1272-2015 TERMINATED D-1254-2015 TERMINATED D-1251-2015 TERMINATED D-1247-2015 TERMINATED D-1263-2015 TERMINATED D-1264-2015 TERMINATED D-1257-2015 TERMINATED D-1260-2015 TERMINATED D-1265-2015 TERMINATED D-1249-2015 TERMINATED D-1250-2015 TERMINATED D-1245-2015 TERMINATED D-1275-2015 TERMINATED D-1273-2015 TERMINATED D-1261-2015 TERMINATED D-1248-2015 TERMINATED D-1277-2015 TERMINATED D-1269-2015 TERMINATED D-1266-2015 TERMINATED D-1259-2015 TERMINATED D-1270-2015 TERMINATED D-1262-2015 TERMINATED D-1256-2015 TERMINATED D-1243-2015 TERMINATED D-1244-2015 TERMINATED D-1274-2015 TERMINATED D-1255-2015 TERMINATED D-1267-2015 TERMINATED D-1258-2015 TERMINATED D-1253-2015 TERMINATED

Recall Number: D-1271-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
A) 136,839 Bottles, B) 37,184 Bottles, C) 309 Pouches, and D) 9,764 Cartons.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0735-02), B) 500 Count Bottles (NDC: 64679-0735-03), C) 4000 Count Pouches, For Repacking Only (NDC: 64679-0735-08), and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0735-09), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Batch or Lot Expiration Information

Lot# A)
Lot# : LN10967, Expiry: 4/30/2015
Lot# : LN10968, Expiry: 4/30/2015
Lot# : LN10969, Expiry: 4/30/2015
Lot# : LN11076, Expiry: 4/30/2015
Lot# : LN11077, Expiry: 4/30/2015
Lot# : LN11078, Expiry: 4/30/2015
Lot# : LN11126, Expiry: 5/31/2015
Lot# : LN11127, Expiry: 5/31/2015
Lot# : LN11326, Expiry: 6/30/2015
Lot# : LN11330, Expiry: 6/30/2015
Lot# : LN11331, Expiry: 6/30/2015
Lot# : LN11335, Expiry: 7/31/2015. B)
Lot# : LN11093, Expiry: 4/30/2015
Lot# : LN11094, Expiry: 4/30/2015
Lot# : LN11095, Expiry: 4/30/2015
Lot# : LN11096, Expiry: 4/30/2015
Lot# : LN11097, Expiry: 4/30/2015
Lot# : LN11101, Expiry: 5/31/2015
Lot# : LN11102, Expiry: 5/31/2015
Lot# : LN11103, Expiry: 5/31/2015
Lot# : LN11107, Expiry: 5/31/2015
Lot# : LN11108, Expiry: 5/31/2015
Lot# : LN11131, Expiry: 5/31/2015
Lot# : LN11132, Expiry: 5/31/2015
Lot# : LN11133, Expiry: 5/31/2015
Lot# : LN11203, Expiry: 5/31/2015
Lot# : LN11204, Expiry: 5/31/2015
Lot# : LN11325, Expiry: 6/30/2015. C)
Lot# : LN10988, Expiry: 4/30/2015. D)
Lot# : LN11192, Expiry: 5/31/2015
Lot# : LN11197, Expiry: 5/31/2015
Lot# :LN11198, Expiry: 5/31/2015.

Recall Number: D-1252-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
A) 33,422 Bottles and B) 940 Bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Metoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0737-02) and B) 500 Count Bottles (NDC: 64679-0737-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA .

Batch or Lot Expiration Information

Lot# A)
Lot# : LN10978, Expiry: 4/30/2015
Lot# : LN11007, Expiry: 4/30/2015
Lot# : LN11013, Expiry: 4/30/2015
Lot# : LN11258, Expiry: 6/30/2015
Lot# : LN11259, Expiry: 6/30/2015
Lot# : LN11277, Expiry: 6/30/2015
Lot# : LN11317, Expiry: 6/30/2015. B)
Lot# : LN11255, Expiry: 6/30/2015.

Recall Number: D-1268-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
16,276 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0669-01.

Batch or Lot Expiration Information

Lot# : LN11008, Expiry: 4/30/2015.

Recall Number: D-1276-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
A) 216,329 Bottles and B) 18,514 Bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0904-01) and B) 1000 Count Bottles (NDC: 64679-0904-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Batch or Lot Expiration Information

Lot# A)
Lot# : LM11093, Expiry: 6/30/2015
Lot# : LM11335, Expiry: 7/31/2015
Lot# : LM11336, Expiry: 7/31/2015
Lot# : LM11461, Expiry: 8/31/2015
Lot# : LM11462, Expiry: 8/31/2015
Lot# : LM11579, Expiry: 8/31/2015
Lot# : LM11778, Expiry: 9/30/2015
Lot# : LM11995, Expiry: 11/30/2015
Lot# : LN10029, Expiry: 11/30/2015
Lot# : LN10071, Expiry: 12/31/2015
Lot# : LN10349, Expiry: 1/31/2016
Lot# : LN10350, Expiry: 1/31/2016
Lot# : LN10505, Expiry: 2/29/2016
Lot# : LN10506, Expiry: 2/29/2016
Lot# : LN10814, Expiry: 3/31/2016
Lot# : LN10815, Expiry: 3/31/2016
Lot# : LN10977, Expiry: 4/30/2016
Lot# : LN11156, Expiry: 6/30/2016
Lot# : LN11260, Expiry: 7/31/2016. B)
Lot# : LM10643, Expiry: 4/30/2015
Lot# : LM10846, Expiry: 5/31/2015
Lot# : LM11347, Expiry: 7/31/2015
Lot# : LM11492, Expiry: 8/31/2015
Lot# : LM11493, Expiry: 8/31/2015
Lot# : LM11577, Expiry: 8/31/2015
Lot# : LM11732, Expiry: 9/30/2015
Lot# : LM11994, Expiry: 11/30/2015
Lot# : LN10072, Expiry: 12/31/2015
Lot# : LN10073, Expiry: 12/31/2015
Lot# : LN10351, Expiry: 1/31/2016
Lot# : LN10561, Expiry: 2/29/2016
Lot# : LN10562, Expiry: 2/29/2016
Lot# : LN10816, Expiry: 3/31/2016
Lot# : LN10817, Expiry: 4/30/2016
Lot# : LN11162, Expiry: 6/30/2016
Lot# : LN11170, Expiry: 6/30/2016
Lot# : LN11171, Expiry: 6/30/2016.

Recall Number: D-1246-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
53,894 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 1000 Count Bottles (NDC: 64679-720-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Batch or Lot Expiration Information

Lot# A)
Lot# : DM11488, Expiry: 4/30/2015
Lot# : DM12093, Expiry: 6/30/2015
Lot# : DM12540, Expiry: 7/31/2015. B)
Lot# : DM11412, Expiry: 4/30/2015
Lot# : DM11642, Expiry: 5/31/2015
Lot# : DM11682, Expiry: 5/31/2015
Lot# : DM12094, Expiry: 6/30/2015
Lot# : DM12533, Expiry: 7/31/2015
Lot# : DM12609, Expiry: 7/31/2015
Lot# : DM12898, Expiry: 9/30/2015
Lot# : DM12899, Expiry: 9/30/2015
Lot# : DN10163, Expiry: 11/30/2015
Lot# : DN10273, Expiry: 11/30/2015
Lot# : DN10487, Expiry: 12/31/2015.

Recall Number: D-1272-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
A) 132,409 Bottles, B) 41,257 Bottles, C) 576 Pouches, and D) 6,429 Cartons.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0734-02), B) 500 Count Bottles (NDC: 64679-0734-03), C) 8000 Count Pouches, For Repacking Only (NDC: 64679-734-08) and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0734-09), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Batch or Lot Expiration Information

Lot# A)
Lot# : LN11050, Expiry: 4/30/2015
Lot# : LN11053, Expiry: 4/30/2015
Lot# : LN11169, Expiry: 5/31/2015
Lot# : LN11312, Expiry: 6/30/2015
Lot# : LN11313, Expiry: 6/30/2015
Lot# : LN11318, Expiry: 6/30/2015. B)
Lot# : LN11030, Expiry: 4/30/2015
Lot# : LN11031, Expiry: 4/30/2015
Lot# : LN11032, Expiry: 4/30/2015
Lot# : LN11038, Expiry: 4/30/2015
Lot# : LN11042, Expiry; 4/30/2015
Lot# : LN11047, Expiry: 4/30/2015
Lot# : LN11173, Expiry: 5/31/2015
Lot# : LN11289, Expiry: 6/30/2015
Lot# : LN11293, Expiry: 6/30/2015. C)
Lot# : LN11185, Expiry: 5/31/2015
Lot# : LN11190, Expiry: 5/31/2015. D)
Lot# : LN11180, Expiry: 5/31/2015.

Recall Number: D-1254-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
491,360 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0990-01.

Batch or Lot Expiration Information

Lot# : LM10776, Expiry: 5/31/2015
Lot# : LM10781, Expiry: 5/31/2015
Lot# : LM10783, Expiry: 5/31/2015
Lot# : LM10923, Expiry: 4/30/2015
Lot# : LM10924, Expiry: 4/30/2015
Lot# : LM10925, Expiry: 4/30/2015
Lot# : LM10926, Expiry: 5/31/2015
Lot# : LM10927, Expiry: 5/31/2015
Lot# : LM10937, Expiry: 6/30/2015
Lot# : LM11138, Expiry: 6/30/2015
Lot# : LM11139, Expiry: 6/30/2015
Lot# : LM11141, Expiry: 6/30/2015
Lot# : LM11180, Expiry: 6/30/2015
Lot# : LM11181, Expiry: 6/30/2015
Lot# : LM11319, Expiry: 7/31/2015
Lot# : LM11320, Expiry: 7/31/2015
Lot# : LM11356, Expiry: 7/31/2015
Lot# : LM11357, Expiry: 7/31/2015
Lot# : LM11363, Expiry: 7/31/2015
Lot# : LM11407, Expiry: 7/31/2015
Lot# : LM11558, Expiry: 8/31/2015
Lot# : LM11730, Expiry: 9/30/2015
Lot# : LM11737, Expiry: 9/30/2015
Lot# : LM11744, Expiry: 9/30/2015
Lot# : LM11754, Expiry: 9/30/2015
Lot# : LM11860, Expiry: 10/31/2015
Lot# : LM11861, Expiry: 10/31/2015
Lot# : LM11904, Expiry: 10/31/2015
Lot# : LM11905, Expiry: 10/31/2015
Lot# : LM11906, Expiry: 10/31/2015
Lot# : LM11964, Expiry: 11/30/2015
Lot# : LN10127, Expiry: 12/31/2015
Lot# : LN10128, Expiry: 12/31/2015
Lot# : LN10137, Expiry: 12/31/2015
Lot# : LN10138, Expiry: 12/31/2015
Lot# : LN10139, Expiry: 12/31/2015
Lot# : LN10140, Expiry: 12/31/2015
Lot# : LN10223, Expiry: 12/31/2015
Lot# : LN10224, Expiry: 12/31/2015
Lot# : LN10235, Expiry: 1/31/2016
Lot# : LN10236, Expiry: 1/31/2016
Lot# : LN10361, Expiry: 1/31/2016
Lot# : LN10362, Expiry: 1/31/2016
Lot# : LN10550, Expiry: 2/29/2016
Lot# : LN10551, Expiry: 2/29/2016
Lot# : LN10552, Expiry: 2/29/2016
Lot# : LN10553, Expiry: 2/29/2016
Lot# : LN10554, Expiry: 2/29/2016
Lot# : LN10606, Expiry: 2/29/2016
Lot# : LN10613, Expiry: 2/29/2016
Lot# : LN10681, Expiry: 3/31/2016
Lot# : LN10752, Expiry: 3/31/2016
Lot# : LN10753, Expiry: 3/31/2016
Lot# : LN10847, Expiry: 4/30/2016
Lot# : LN10944, Expiry: 4/30/2016
Lot# : LN10954, Expiry: 4/30/2016
Lot# : LN10955, Expiry: 4/30/2016
Lot# : LN11091, Expiry: 5/31/2016
Lot# : LN11092, Expiry: 5/31/2016
Lot# : LN11104, Expiry: 5/31/2016
Lot# : LN11112, Expiry: 5/31/2016
Lot# : LN11231, Expiry: 6/30/2016
Lot# : LN11232, Expiry: 6/30/2016
Lot# : LN11241, Expiry: 7/31/2016
Lot# : LN11282, Expiry: 7/31/2016
Lot# : LN11355, Expiry: 8/31/2016
Lot# : LN11358, Expiry: 8/31/2016
Lot# : LN11361, Expiry: 8/31/2016
Lot# : LN11399, Expiry: 9/30/2016.

Recall Number: D-1251-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
848 Pouches

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging Only, Packaged in 4500 Count Pouches, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-140-00.

Batch or Lot Expiration Information

Lot# : LN11086, Expiry: 5/31/2015.

Recall Number: D-1247-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
37,791 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-714-01.

Batch or Lot Expiration Information

Lot# : DM11802, Expiry: 6/30/2015
Lot# : DM11803, Expiry: 6/30/2015
Lot# : DM12273, Expiry: 7/31/2015
Lot# : DM12274, Expiry: 7/31/2015.

Recall Number: D-1263-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
A) 112,120 Bottles and B) 178,580 Cartons.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet Card Cartons (NDC: 64679-964-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Batch or Lot Expiration Information

Lot# A)
Lot# : LM10739, Expiry: 4/30/2015
Lot# : LM10991, Expiry: 5/31/2015
Lot# : LM11264, Expiry: 6/30/2015
Lot# : LM12019, Expiry: 11/30/2015
Lot# : LN10100, Expiry: 12/31/2015
Lot# : LN10220, Expiry: 12/31/2015
Lot# : LN10227, Expiry: 12/31/2015
Lot# : LN10228, Expiry: 12/31/2015
Lot# : LN11405, Expiry: 9/30/2016. B)
Lot# : LM11015, Expiry: 5/31/2015
Lot# : LM11609, Expiry: 9/30/2015
Lot# : LM11883, Expiry: 10/31/2015
Lot# : LM11918, Expiry: 10/31/2015
Lot# : LN10274, Expiry: 12/31/2015
Lot# : LN11045, Expiry: 4/30/2016
Lot# : LN11327, Expiry: 12/31/2015
Lot# : LN11332, Expiry: 7/31/2016.

Recall Number: D-1264-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
7,584 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-962-01.

Batch or Lot Expiration Information

Lot# : LN10991, Expiry: 4/30/2015
Lot# : LN11381, Expiry: 7/31/2015.

Recall Number: D-1257-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
A) 128,594 Bottles, B) 25,472 Bottles, and C) 62,124 Bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500 Count Bottles (NDC: 64679-928-05), and C) 1000 Count Bottles (NDC: 64679-928-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Batch or Lot Expiration Information

Lot# A)
Lot# : DM10991, Expiry: 4/30/2015
Lot# : DM11226, Expiry: 4/30/2015
Lot# : DM11665, Expiry: 6/30/2015
Lot# : DM11810, Expiry: 6/30/2015
Lot# : DM12702, Expiry: 9/30/2015
Lot# : DN10719, Expiry: 1/31/2016. B)
Lot# : DM11651, Expiry: 6/30/2015
Lot# : DM11652, Expiry: 6/30/2015
Lot# : DM11664, Expiry: 6/30/2015
Lot# : DM12701, Expiry: 9/30/2015
Lot# : DN10139, Expiry: 12/31/2015. C)
Lot# : DM11041, Expiry: 4/30/2015
Lot# : DM11267, Expiry: 4/30/2015
Lot# : DM11268, Expiry: 4/30/2015
Lot# : DM11279, Expiry: 5/31/2015
Lot# : DM11286, Expiry: 5/31/2015
Lot# : DM11292, Expiry: 5/31/2015
Lot# : DM11625, Expiry: 6/30/2015
Lot# : DM11626, Expiry: 6/30/2015
Lot# : DM11670, Expiry: 6/30/2015
Lot# : DM11772, Expiry: 6/30/2015
Lot# : DM11773, Expiry: 6/30/2015
Lot# : DM11809, Expiry: 6/30/2015
Lot# : DM12698, Expiry: 9/30/2015
Lot# : DN10110, Expiry: 11/30/2015
Lot# : DN10608, Expiry: 1/31/2016
Lot# : DN10642, Expiry: 1/31/2016
Lot# : DN10694, Expiry: 1/31/2016
Lot# : DN10744, Expiry: 1/31/2016
Lot# : DN10799, Expiry: 1/31/2016
Lot# : DN10839; Expiry: 2/29/2016.

Recall Number: D-1260-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
A) 63,203 Bottles and B) 6,094 Bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Lisinopril Tablets USP, 30 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-953-01) and B) 500 Count Bottles (NDC: 64679-953-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Batch or Lot Expiration Information

Lot# A)
Lot# : DM11003, Expiry: 4/30/2015
Lot# : DM11094, Expiry: 4/30/2015
Lot# : DM11689, Expiry: 6/30/2015
Lot# : DM11873, Expiry: 6/30/2015
Lot# : DM11874, Expiry: 6/30/2015
Lot# : DM12402, Expiry: 8/31/2015
Lot# : DM12412, Expiry: 8/31/2015
Lot# : DM13440, Expiry: 11/30/2015
Lot# : DN10689, Expiry: 1/31/2016
Lot# : DN10693, Expiry: 1/31/2016. B)
Lot# : DM11095, Expiry: 4/30/2015
Lot# : DM11688, Expiry: 6/30/2015
Lot# : DM11860, Expiry: 6/30/2015
Lot# : DM12413, Expiry: 8/31/2015
Lot# : DN10692, Expiry: 1/31/2016.

Recall Number: D-1265-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
A) 69,008 Bottles, B) 399,730 Bottles, and C) 58,116 Bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-936-01), B) 100 Count Bottles(NDC: 64679-936-02), and C) 1000 Count Bottles (NDC: 64679-936-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Batch or Lot Expiration Information

Lot# A)
Lot# : LM10708, Expiry: 4/30/2015
Lot# : LM10859, Expiry: 5/31/2015
Lot# : LM11200, Expiry: 7/31/2015
Lot# : LM11679, Expiry: 9/30/2015
Lot# : LN10465, Expiry: 1/31/2016
Lot# : LN10750, Expiry: 3/31/2016
Lot# : LN11385, Expiry: 9/30/2016. B)
Lot# : LM10709, Expiry: 4/30/2015
Lot# : LM10719, Expiry: 4/30/2015
Lot# : LM10721, Expiry: 4/30/2015
Lot# : LM10827, Expiry: 5/31/2015
Lot# : LM10828, Expiry: 5/31/2015
Lot# : LM10912, Expiry: 5/31/2015
Lot# : LM11205, Expiry: 7/31/2015
Lot# : LM11206, Expiry: 7/31/2015
Lot# : LM11239. Expiry: 7/31/2015
Lot# : LM11680, Expiry: 9/30/2015
Lot# : LM11822, Expiry: 10/31/2015
Lot# : LM11993, Expiry: 10/31/2015
Lot# : LN10114, Expiry: 12/31/2015
Lot# : LN10115, Expiry: 12/31/2015
Lot# : LN10695, Expiry: 3/31/2016
Lot# : LN10696, Expiry: 3/31/2016
Lot# : LN10697, Expiry: 3/31/2016
Lot# : LN10745, Expiry: 3/31/2016
Lot# : LN10749, Expiry: 3/31/2016
Lot# : LN11249, Expiry: 6/30/2016
Lot# : LN11374, Expiry: 8/31/2016
Lot# : LN11376, Expiry: 8/31/2016
Lot# : LN11382, Expiry: 7/31/2016
Lot# : LN11386, Expiry: 9/30/2016. C)
Lot# : LM10685, Expiry: 4/30/2015
Lot# : LM10687, Expiry: 4/30/2015
Lot# : LM10691, Expiry: 4/30/2015
Lot# : LM10692, Expiry: 4/30/2015
Lot# : LM10707, Expiry: 4/30/2015
Lot# : LM10735, Expiry: 4/30/2015
Lot# : LM10741, Expiry: 4/30/2015
Lot# : LM10743, Expiry: 4/30/2015
Lot# : LM10860, Expiry: 5/31/2015
Lot# : LM10861, Expiry: 5/31/2015
Lot# : LM10862, Expiry: 5/31/2015
Lot# : LM10869, Expiry: 5/31/2015
Lot# : LM10911, Expiry: 5/31/2015
Lot# : LM11158, Expiry: 4/30/2015
Lot# : LM12039, Expiry: 10/31/2015
Lot# : LN10426, Expiry: 1/31/2016
Lot# : LN10427, Expiry: 1/31/2016
Lot# : LN10428, Expiry: 1/31/2016
Lot# : LN10435, Expiry: 1/31/2016
Lot# : LN10463, Expiry: 1/31/2016
Lot# : LN10464, Expiry: 1/31/2016
Lot# : LN10674, Expiry: 3/31/2016
Lot# : LN10675, Expiry: 3/31/2016
Lot# : LN10676, Expiry: 3/31/2016
Lot# : LN10751, Expiry: 3/31/2016
Lot# : LN11017, Expiry: 5/31/2016
Lot# : LN11018, Expiry: 5/31/2016
Lot# : LN11023, Expiry: 5/31/2016
Lot# : LN11216, Expiry: 6/30/2016
Lot# : LN11217, Expiry: 6/30/2016
Lot# : LN11391, Expiry: 9/30/2016
Lot# : LN11394, Expiry: 9/30/2016
Lot# : LN11401, Expiry: 9/30/2016
Lot# : LN11408, Expiry: 9/30/2016
Lot# : LN11410, Expiry: 9/30/2016.

Recall Number: D-1249-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
59,729 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-949-01.

Batch or Lot Expiration Information

Lot# : LM11172, Expiry: 6/30/2015
Lot# : LN10487, Expiry: 1/31/2016
Lot# : LN10488, Expiry: 1/31/2016
Lot# : LN10489, Expiry: 2/29/2016
Lot# : LN10578, Expiry: 2/29/2016
Lot# : LN10581, Expiry: 2/29/2016
Lot# : LN10582, Expiry: 2/29/2016
Lot# : LN11068, Expiry: 4/30/2016
Lot# : LN11073, Expiry: 4/30/2016
Lot# : LN11125, Expiry: 5/31/2016
Lot# : LN11362, Expiry: 8/31/2016
Lot# : LN11379, Expiry: 8/31/2016
Lot# : LN11380, Expiry: 8/31/2016.

Recall Number: D-1250-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
A) 70,428 Bottles, B) 128,420 Bottles, and C) 8,101 Bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bottles (NDC: 64679-937-02), and C) 1000 Count Bottles (NDC: 64679-937-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Batch or Lot Expiration Information

Lot# A)
Lot# : LM10806, Expiry: 5/31/2015
Lot# : LM11099, Expiry: 6/30/2015
Lot# : LM11297, Expiry: 7/31/2015
Lot# : LM11933, Expiry: 10/31/2015
Lot# : LN10180, Expiry: 12/31/2015
Lot# : LN10547, Expiry: 2/29/2016. B)
Lot# : LM10784, Expiry: 5/31/2015
Lot# : LM10791, Expiry: 5/31/2015
Lot# : LM10812, Expiry: 5/31/2015
Lot# : LM11112, Expiry: 6/30/2015
Lot# : LM11298, Expiry: 7/31/2015
Lot# : LM11299, Expiry: 7/31/2015
Lot# : LM11625, Expiry: 8/31/2015
Lot# : LN10182, Expiry: 12/31/2015
Lot# : LN10548, Expiry: 2/29/2016
Lot# : LN11115, Expiry: 5/31/2016
Lot# : LN11367, Expiry: 8/31/2016
Lot# : LN11369, Expiry: 8/31/2016. C)
Lot# : LM10813, Expiry: 5/31/2015
Lot# : LM11085, Expiry: 6/30/2015
Lot# : LM11088, Expiry: 6/30/2015
Lot# : LM11296, Expiry: 7/31/2015
Lot# : LM11932, Expiry: 10/31/2015
Lot# : LN10181, Expiry: 12/31/2015
Lot# : LN10549, Expiry: 2/29/2016
Lot# : LN11114, Expiry: 5/31/2016
Lot# : LN11359, Expiry: 8/31/2016.

Recall Number: D-1245-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
5,910 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Lamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-271-01.

Batch or Lot Expiration Information

Lot# : DN10114, Expiry: 11/30/2015.

Recall Number: D-1275-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
A) 162,743 Bottles and B) 14,205 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0903-01) and B) 1000 Count Bottles (NDC: 64679-0903-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Batch or Lot Expiration Information

Lot# A)
Lot# : LM10843, Expiry: 5/31/2015
Lot# : LM11331, Expiry: 7/31/2015
Lot# : LM11332, Expiry: 7/31/2015
Lot# : LM11376, Expiry: 7/31/2015
Lot# : LM11583, Expiry: 8/31/2015
Lot# : LM11987, Expiry: 11/30/2015
Lot# : LN10065, Expiry: 12/31/2015
Lot# : LN10066, Expiry: 12/31/2015
Lot# : LN10334, Expiry: 1/31/2016
Lot# : LN10335, Expiry: 1/31/2016
Lot# : LN10443, Expiry: 1/31/2016
Lot# : LN10879, Expiry: 4/30/2016
Lot# : LN10971, Expiry: 4/30/2016
Lot# : LN11178, Expiry: 6/30/2016
Lot# : LN11184, Expiry: 6/30/2016
Lot# : LN11348, Expiry: 7/31/2016. B)
Lot# : LM10683, Expiry: 4/30/2015
Lot# : LM10842, Expiry: 5/31/2015
Lot# : LM11377, Expiry: 7/31/2015
Lot# : LM11584, Expiry: 8/31/2015
Lot# : LM11985, Expiry: 11/30/2015
Lot# : LM11988, Expiry: 11/30/2015
Lot# : LN10064, Expiry: 12/31/2015
Lot# : LN10336, Expiry: 1/31/2016
Lot# : LN10446, Expiry: 1/31/2016
Lot# : LN10880, Expiry: 4/30/2016
Lot# : LN10883, Expiry: 4/30/2016
Lot# : LN10972, Expiry: 4/30/2016
Lot# : LN11177, Expiry: 6/30/2016
Lot# : LN11256, Expiry: 7/31/2016.

Recall Number: D-1273-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
84,542 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Zonisamide Capsules, 50 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0946-01.

Batch or Lot Expiration Information

Lot# : LM10769, Expiry: 4/30/2015
Lot# : LM10770, Expiry: 4/30/2015
Lot# : LM10771, Expiry: 4/30/2015
Lot# : LM10875, Expiry: 5/31/2015
Lot# : LM10876, Expiry: 5/31/2015
Lot# : LM11145, Expiry: 6/30/2015
Lot# : LM11174, Expiry: 6/30/2015
Lot# : LM11175, Expiry: 6/30/2015
Lot# : LM11226, Expiry: 7/31/2015
Lot# : LM11227, Expiry: 7/31/2015
Lot# : LM11289, Expiry: 7/31/2015
Lot# : LM11290, Expiry: 7/31/2015
Lot# : LM11544, Expiry: 8/31/2015
Lot# : LM11545, Expiry: 8/31/2015
Lot# : LM11671, Expiry: 9/30/2015
Lot# : LM11947, Expiry: 10/31/2015
Lot# : LM11948, Expiry: 10/31/2015
Lot# : LM11949, Expiry: 10/31/2015
Lot# : LM11950, Expiry: 10/31/2015
Lot# : LN10208, Expiry: 12/31/2015
Lot# : LN10209, Expiry: 12/31/2015
Lot# : LN10210, Expiry: 12/31/2015
Lot# : LN10211, Expiry: 12/31/2015
Lot# : LN10212, Expiry: 12/31/2015
Lot# : LN10213, Expiry: 12/31/2015
Lot# : LN10354, Expiry: 1/31/2016
Lot# : LN10355, Expiry: 1/31/2016
Lot# : LN10526, Expiry: 2/29/2016
Lot# : LN10527, Expiry: 2/29/2016
Lot# : LN10528, Expiry: 2/29/2016
Lot# : LN10529, Expiry: 2/29/2016
Lot# : LN10541, Expiry: 2/29/2016
Lot# : LN10840, Expiry: 4/30/2016
Lot# : LN11113, Expiry: 5/31/2016
Lot# : LN11333, Expiry: 7/31/2016
Lot# : LN11377, Expiry: 8/31/2016.

Recall Number: D-1261-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
A) 174,571 Bottles, B) 66,960 Bottles, and C) 48,988 Bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Lisinopril Tablets USP, 40 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-942-01), B) 500 Count Bottles (NDC: 64679-942-05), and C) 1000 Count Bottles (NDC: 64679-942-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Batch or Lot Expiration Information

Lot# A)
Lot# : DM11040, Expiry: 4/30/2015
Lot# : DM11463, Expiry: 5/31/2015
Lot# : DM11497, Expiry: 5/31/2015
Lot# : DM11498, Expiry: 5/31/2015
Lot# : DM12126, Expiry: 7/31/2015
Lot# : DM12132, Expiry: 7/31/2015
Lot# : DM12172, Expiry: 7/31/2015
Lot# : DM12176, Expiry: 7/31/2015
Lot# : DN10325, Expiry: 12/31/2015
Lot# : DN10892, Expiry: 2/29/2016. B)
Lot# : DM11812, Expiry: 6/30/2015
Lot# : DM11816, Expiry: 6/30/2015
Lot# : DM11821, Expiry: 6/30/2015
Lot# : DM11822, Expiry: 6/30/2015
Lot# : DM11827, Expiry: 6/30/2015
Lot# : DM11828, Expiry: 6/30/2015
Lot# : DM11853, Expiry: 6/30/2015
Lot# : DM11856, Expiry: 6/30/2015
Lot# : DM12517, Expiry: 8/31/2015
Lot# : DM12519, Expiry: 8/31/2015
Lot# : DM12528, Expiry: 8/31/2015
Lot# : DM12529, Expiry: 8/31/2015
Lot# : DM12534, Expiry: 8/31/2015
Lot# : DM12535, Expiry: 8/31/2015. C)
Lot# : DM11018, Expiry: 4/30/2015
Lot# : DM11019, Expiry: 4/30/2015
Lot# : DM11028, Expiry: 4/30/2015
Lot# : DM11029, Expiry: 4/30/2015
Lot# : DM11049, Expiry: 4/30/2015
Lot# : DM11050, Expiry: 4/30/2015
Lot# : DM11468, Expiry: 5/31/2015
Lot# : DM11469, Expiry: 5/31/2015
Lot# : DM11480, Expiry: 5/31/2015
Lot# : DM11483, Expiry: 5/31/2015
Lot# : DM12087, Expiry: 7/31/2015
Lot# : DM12095, Expiry: 7/31/2015
Lot# : DM12112, Expiry: 7/31/2015
Lot# : DM12129, Expiry: 7/31/2015
Lot# : DM12140, Expiry: 7/31/2015
Lot# : DM12141, Expiry: 7/31/2015
Lot# : DM12177, Expiry: 7/31/2015
Lot# : DM12499, Expiry: 8/31/2015
Lot# : DM12505, Expiry: 8/31/2015
Lot# : DM12509, Expiry: 8/31/2015
Lot# : DM12510, Expiry: 8/31/2015
Lot# : DM13306, Expiry: 11/30/2015
Lot# : DM13307, Expiry: 11/30/2015
Lot# : DM13313, Expiry: 11/30/2015
Lot# : DN10316, Expiry: 12/31/2015
Lot# : DN10332, Expiry: 12/31/2015
Lot# : DN10333, Expiry: 12/31/2015
Lot# : DN10348, Expiry: 12/31/2015
Lot# : DN10353, Expiry: 12/31/2015
Lot# : DN10369, Expiry: 12/31/2015
Lot# : DN10374, Expiry: 12/31/2015
Lot# : DN10375, Expiry: 12/31/2015
Lot# : DN10396, Expiry: 12/31/2015
Lot# : DN10854, Expiry: 2/29/2016
Lot# : DN10855, Expiry: 2/29/2016
Lot# : DN10872, Expiry: 2/29/2016.

Recall Number: D-1248-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
A) 280,520 Bottles, B) 571 Pouches, and C) 1,629,253 Cartons.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) 3,500 Count Pouches (NDC: 64679-961-08), and C) 3 x 6 Tablet Card Cartons (NDC: 64679-961-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Batch or Lot Expiration Information

Lot# A)
Lot# : LM10712, Expiry: 4/30/2015
Lot# : LM10874, Expiry: 4/30/2015
Lot# : LM11040, Expiry: 5/31/2015
Lot# : LM11169, Expiry: 6/30/2015
Lot# : LM11401, Expiry: 6/30/2015
Lot# : LM12132, Expiry: 11/30/2015
Lot# : LN10039, Expiry: 12/31/2015
Lot# : LN10263, Expiry: 12/31/2015
Lot# : LN10276, Expiry: 12/31/2015
Lot# : LN10417, Expiry: 1/31/2016
Lot# : LN11365, Expiry: 8/31/2016. B)
Lot# : LN11264, Expiry: 7/31/2015
Lot# : LN11373, Expiry: 8/31/2015
Lot# : LN11375, Expiry: 8/31/2015. C)
Lot# : LM10686, Expiry: 4/30/2015
Lot# : LM10757, Expiry: 4/30/2015
Lot# : LM10855, Expiry: 4/30/2015
Lot# : LM10893, Expiry: 5/31/2015
Lot# : LM10945, Expiry: 5/31/2015
Lot# : LM10989, Expiry: 4/30/2015
Lot# : LM11117, Expiry: 6/30/2015
Lot# : LM11168, Expiry: 6/30/2015
Lot# : LM11214, Expiry: 6/30/2015
Lot# : LM11624, Expiry: 9/30/2015
Lot# : LM11797, Expiry: 10/31/2015
Lot# : LM11820, Expiry: 10/31/2015
Lot# : LM11959, Expiry: 10/31/2015
Lot# : LM12000, Expiry: 10/31/2015
Lot# : LM12027, Expiry: 11/30/2015
Lot# : LM12128, Expiry: 11/30/2015
Lot# : LN10014, Expiry: 11/30/2015
Lot# : LN10055, Expiry: 11/30/2015
Lot# : LN10089, Expiry: 11/30/2015
Lot# : LN10122, Expiry: 11/30/2015
Lot# : LN10156, Expiry: 12/31/2015
Lot# : LN10196, Expiry: 12/31/2015
Lot# : LN10225, Expiry: 12/31/2015
Lot# : LN10307, Expiry: 1/31/2016
Lot# : LN10338, Expiry: 1/31/2016
Lot# : LN10382, Expiry: 1/31/2016
Lot# : LN10416, Expiry: 1/31/2016
Lot# : LN10431, Expiry: 1/31/2016
Lot# : LN10461, Expiry: 1/31/2016
Lot# : LN10618, Expiry: 2/29/2016
Lot# : LN11144, Expiry: 5/31/2016
Lot# : LN11183, Expiry: 6/30/2016
Lot# : LN11236, Expiry: 6/30/2016
Lot# : LN11276, Expiry: 7/31/2016
Lot# : LN11347, Expiry: 7/31/2016
Lot# : LN11360, Expiry: 7/31/2016
Lot# : LN11366, Expiry: 8/31/2016
Lot# : LN11372, Expiry: 8/31/2016
Lot# : LN11395, Expiry: 9/30/2016
Lot# : LN11404, Expiry: 9/30/2016
Lot# : LN11419, Expiry: 9/30/2016.

Recall Number: D-1277-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
68,969 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Captopril Tablets, USP, 100 mg Tablets, Packaged in 100 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0905-01.

Batch or Lot Expiration Information

Lot# : LM11354, Expiry: 7/31/2015
Lot# : LM11355, Expiry: 7/31/2015
Lot# : LM11374, Expiry: 7/31/2015
Lot# : LM11626, Expiry: 8/31/2015
Lot# : LM12004, Expiry: 11/30/2015
Lot# : LM12005, Expiry: 11/30/2015
Lot# : LN10080, Expiry: 10/31/2015
Lot# : LN10393, Expiry: 1/31/2016
Lot# : LN10447, Expiry: 1/31/2016
Lot# : LN10736, Expiry: 2/29/2016
Lot# : LN11316, Expiry: 7/31/2016.

Recall Number: D-1269-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
A) 178,832 Bottles, B) 15,787 Bottles, and C) 459 Bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules, Packaged in A) 30 Count Bottles (NDC: 64679-0670-01), B) 90 Count Bottles (NDC: 64679-0670-07), and C) 1000 Count Bottles (NDC: 64679-0670-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Batch or Lot Expiration Information

Lot# A)
Lot# : LN10933, Expiry: 4/30/2015
Lot# : LN10935, Expiry: 4/30/2015
Lot# : LN11063, Expiry: 4/30/2015. B)
Lot# : LN10987, Expiry: 4/30/2015
Lot# : LN11415, Expiry: 6/30/2015. C)
Lot# : LN10986, Expiry: 4/30/2015
Lot# : LN11414, Expiry: 6/30/2015.

Recall Number: D-1266-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
539 Drums

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0374-09.

Batch or Lot Expiration Information

Lot# : LN11320, Expiry: 7/31/2015
Lot# : LN11341, Expiry: 8/31/2015.

Recall Number: D-1259-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
A) 121,608 Bottles, B) 11,000 Bottles, and C) 152,773 Bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Lisinopril Tablets USP, 20 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-941-01), B) 500 Count Bottles (NDC: 64679-941-05), and C) 1000 Count Bottles (NDC: 64679-941-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Batch or Lot Expiration Information

Lot# A)
Lot# : DM11334, Expiry: 4/30/2015
Lot# : DM11551, Expiry: 6/30/2015
Lot# : DM11995, Expiry: 7/31/2015
Lot# : DM12007, Expiry: 7/31/2015
Lot# : DM12480, Expiry: 8/31/2015
Lot# : DN10255, Expiry: 12/31/2015
Lot# : DN10410, Expiry: 1/31/2016
Lot# : DN10897, Expiry: 2/29/2016. B)
Lot# : DM11556, Expiry: 6/30/2015
Lot# : DM11567, Expiry: 6/30/2015
Lot# : DM12008, Expiry: 7/31/2015
Lot# : DM12482, Expiry: 8/31/2015. C)
Lot# : DM11119, Expiry: 4/30/2015
Lot# : DM11131, Expiry: 4/30/2015
Lot# : DM11132, Expiry: 4/30/2015
Lot# : DM11144, Expiry: 4/30/2015
Lot# : DM11145, Expiry: 4/30/2015
Lot# : DM11161, Expiry: 4/30/2015
Lot# : DM11162, Expiry: 4/30/2015
Lot# : DM11181, Expiry: 4/30/2015
Lot# : DM11182, Expiry: 4/30/2015
Lot# : DM11185, Expiry: 4/30/2015
Lot# : DM11335, Expiry: 5/31/2015
Lot# : DM11352, Expiry: 5/31/2015
Lot# : DM11357, Expiry: 5/31/2015
Lot# : DM11358, Expiry: 5/31/2015:
Lot# : DM11366, Expiry: 5/31/2015
Lot# : DM11367, Expiry: 5/31/2015:
Lot# : DM11390, Expiry: 5/31/2015
Lot# : DM11396, Expiry: 5/31/2015
Lot# : DM11397, Expiry: 5/31/2015
Lot# : DM11407, Expiry: 5/31/2015
Lot# : DM11408, Expiry: 5/31/2015
Lot# : DM11410, Expiry: 5/31/2015
Lot# : DM11427, Expiry: 5/31/2015
Lot# : DM11428, Expiry: 5/31/2015
Lot# : DM11443, Expiry: 5/31/2015
Lot# : DM11983, Expiry: 7/31/2015
Lot# : DM11984, Expiry: 7/31/2015
Lot# : DM11985, Expiry: 7/31/2015
Lot# : DM11986, Expiry: 7/31/2015
Lot# : DM11996, Expiry: 7/31/2015
Lot# : DM12005, Expiry: 7/31/2015
Lot# : DM12006, Expiry: 7/31/2015
Lot# : DM12045, Expiry: 7/31/2015
Lot# : DM12046, Expiry: 7/31/2015
Lot# : DM12056, Expiry: 7/31/2015
Lot# : DM12057, Expiry: 7/31/2015
Lot# : DM12061, Expiry: 7/31/2015
Lot# : DM12065, Expiry: 7/31/2015
Lot# : DM12079, Expiry: 7/31/2015
Lot# : DM12080, Expiry: 7/31/2015
Lot# : DM12453, Expiry: 8/31/2015
Lot# : DM12455, Expiry: 8/31/2015
Lot# : DM12466, Expiry: 8/31/2015
Lot# : DM12467, Expiry: 8/31/2015
Lot# : DM12478, Expiry: 8/31/2015
Lot# : DM12479, Expiry: 8/31/2015
Lot# : DM13072, Expiry: 10/31/2015
Lot# : DM13093, Expiry: 10/31/2015
Lot# : DM13098, Expiry: 10/31/2015
Lot# : DM13099, Expiry: 10/31/2015
Lot# : DM13220, Expiry: 10/31/2015
Lot# : DM13221, Expiry: 10/31/2015
Lot# : DM13362, Expiry: 11/30/2015
Lot# : DM13363, Expiry: 11/30/2015
Lot# : DM13386, Expiry: 11/30/2015
Lot# : DM13392, Expiry: 11/30/2015
Lot# : DM13414, Expiry: 11/30/2015:
Lot# : DM13441, Expiry: 11/30/2015
Lot# : DM13454, Expiry: 11/30/2015
Lot# : DN10253, Expiry: 12/31/2015
Lot# : DN10254, Expiry: 12/31/2015
Lot# : DN10261, Expiry: 12/31/2015
Lot# : DN10262, Expiry: 12/31/2015
Lot# : DN10282, Expiry: 12/31/2015
Lot# : DN10283, Expiry: 12/31/2015
Lot# : DN10284, Expiry: 12/31/2015
Lot# : DN10293, Expiry: 12/31/2015
Lot# : DN10294, Expiry: 12/31/2015
Lot# : DN10295, Expiry: 12/31/2015
Lot# : DN10309, Expiry: 12/31/2015
Lot# : DN10411, Expiry: 1/31/2016
Lot# : DN10455, Expiry: 1/31/2016
Lot# : DN10464, Expiry: 1/31/2016
Lot# : DN10485, Expiry: 1/31/2016
Lot# : DN10497, Expiry: 1/31/2016
Lot# : DN10505, Expiry: 1/31/2016
Lot# : DN10506, Expiry: 1/31/2016
Lot# : DN10524, Expiry: 1/31/2016
Lot# : DN10534, Expiry: 1/31/2016
Lot# : DN10535, Expiry: 1/31/2016
Lot# : DN10554, Expiry: 1/31/2016
Lot# : DN10555, Expiry: 1/31/2016
Lot# : DN10909, Expiry: 2/29/2016
Lot# : DN10910, Expiry: 2/29/2016
Lot# : DN10923, Expiry: 2/29/2016
Lot# : DN10928, Expiry: 3/31/2016
Lot# : DN10929, Expiry: 3/31/2016
Lot# : DN10954, Expiry: 3/31/2016
Lot# : DN10970, Expiry: 3/31/2016
Lot# : DN10971, Expiry: 3/31/2016
Lot# : DN10986, Expiry: 3/31/2016
Lot# : DN10987, Expiry: 3/31/2016.

Recall Number: D-1270-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
A) 77,967 Bottles, B) 26,785 Bottles, and C) 5,463 Cartons.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0736-02), B) 500 Count Bottles (NDC: 64679-0736-03), and C) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0736-09), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC, 20 Waterview Blvd. Parsippany, NJ 07054 USA .

Batch or Lot Expiration Information

Lot# A)
Lot# : LN11010, Expiry: 4/30/2015
Lot# : LN11011, Expiry: 4/30/2015
Lot# : LN11135, Expiry: 5/31/2015
Lot# : LN11136, Expiry: 5/31/2015
Lot# : LN11137, Expiry: 5/31/2015
Lot# : LN11138, Expiry: 5/31/2015
Lot# : LN11242, Expiry: 6/30/2015
Lot# : LN11243, Expiry: 6/30/2015. B)
Lot# : LN11033, Expiry: 4/30/2015
Lot# : LN11034, Expiry: 4/30/2015
Lot# : LN11157, Expiry: 5/31/2015
Lot# : LN11158, Expiry: 5/31/2015
Lot# : LN11159, Expiry: 5/31/2015
Lot# : LN11160, Expiry: 5/31/2015
Lot# : LN11218, Expiry: 5/31/2015
Lot# : LN11219, Expiry: 5/31/2015
Lot# : LN11220, Expiry: 5/31/2015
Lot# : LN11222, Expiry: 6/30/2015
Lot# : LN11403, Expiry: 6/30/2015
Lot# : LN11413, Expiry: 8/31/2015
Lot# : LN11417, Expiry: 8/31/2015
Lot# : LN11418, Expiry: 8/31/2015. C)
Lot# : LN10996, Expiry: 4/30/2015
Lot# : LN11172, Expiry: 5/31/2015.

Recall Number: D-1262-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
A) 36,213 Bottles and B) 12,824 Bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bottles (NDC: 64679-715-04), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Batch or Lot Expiration Information

Lot# A)
Lot# : DM11608, Expiry: 5/31/2015
Lot# : DM11609, Expiry: 5/31/2015
Lot# : DN10190, Expiry: 12/31/2015. B)
Lot# : DM11186, Expiry: 4/30/2015
Lot# : DM11607, Expiry: 5/31/2015
Lot# : DM13298, Expiry: 10/31/2015
Lot# : DN10188, Expiry: 12/31/2015
Lot# : DN10189, Expiry: 12/31/2015.

Recall Number: D-1256-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
A) 152,164 Bottles and B) 50,991 Bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000 Count Bottles (NDC: 64679-423-02, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Batch or Lot Expiration Information

Lot# A)
Lot# : DM12975, Expiry: 10/31/2015
Lot# : DM12976, Expiry: 10/31/2015
Lot# : DM12977, Expiry:10/31/2015
Lot# : DM12986, Expiry: 10/31/2015
Lot# : DM13259. Expiry: 10/31/2015
Lot# : DM13269, Expiry: 10/31/2015
Lot# : DM13270, Expiry: 11/30/2015
Lot# : DM13275, Expiry: 11/30/2015
Lot# : DM13339, Expiry: 11/30/2015
Lot# : DM13341, Expiry: 11/30/2015
Lot# : DM13369, Expiry: 11/30/2015
Lot# : DM13370, Expiry: 11/30/2015
Lot# : DN10088, Expiry: 12/31/2015
Lot# : DN10099, Expiry: 12/31/2015
Lot# : DN10939, Expiry: 3/31/2016
Lot# : DN10940, Expiry: 3/31/2016. B)
Lot# : DM11422, Expiry: 5/31/2015
Lot# : DM11423, Expiry: 5/31/2015
Lot# : DM11424, Expiry: 5/31/2015
Lot# : DM11425, Expiry: 5/31/2015
Lot# : DM12634, Expiry: 9/30/2015
Lot# : DM12635; Expiry: 9/30/2015
Lot# : DM12660, Expiry: 9/30/2015
Lot# : DM12661, Expiry: 9/30/2015
Lot# : DM12662, Expiry: 9/30/2015
Lot# : DM12663, Expiry: 9/30/2015
Lot# : DM12673, Expiry: 9/30/2015
Lot# : DM12674, Expiry: 9/30/2015
Lot# : DM12684, Expiry: 9/30/2015
Lot# : DM12685, Expiry: 9/30/2015
Lot# : DM12985, Expiry: 10/31/2015
Lot# : DM13162, Expiry: 10/31/2015
Lot# : DM13163, Expiry: 10/31/2015
Lot# : DM13195, Expiry: 10/31/2015
Lot# : DM13196, Expiry: 10/31/2015
Lot# : DM13222, Expiry: 10/31/2015
Lot# : DM13223, Expiry: 10/31/2015
Lot# : DM13271, Expiry: 11/30/2015
Lot# : DM13272, Expiry: 11/30/2015
Lot# : DM13273, Expiry: 11/30/2015
Lot# : DM13274, Expiry: 11/30/2015
Lot# : DM13281, Expiry: 11/30/2015
Lot# : DM13282, Expiry: 11/30/2015
Lot# : DM13296, Expiry: 11/30/2015
Lot# : DM13297, Expiry: 11/30/2015:
Lot# : DM13393, Expiry: 11/30/2015
Lot# : DM13394, Expiry: 11/30/2015
Lot# : DM13395, Expiry: 11/30/2015
Lot# : DM13403, Expiry: 11/30/2015
Lot# : DM13404, Expiry: 11/30/2015
Lot# : DM13415, Expiry: 11/30/2015
Lot# : DM13429, Expiry: 11/30/2015
Lot# : DN10077, Expiry: 12/31/2015
Lot# : DN10078, Expiry: 12/31/2015
Lot# : DN10079, Expiry: 12/31/2015
Lot# : DN10080, Expiry: 12/31/2015
Lot# : DN10081, Expiry: 12/31/2015
Lot# : DN10100, Expiry: 12/31/2015
Lot# : DN10104, Expiry: 12/31/2015
Lot# : DN10105, Expiry: 12/31/2015
Lot# : DN10336, Expiry: 12/31/2015
Lot# : DN10342, Expiry: 12/31/2015
Lot# : DN10343, Expiry: 12/31/2015
Lot# : DN10344, Expiry: 12/31/2015
Lot# : DN10355, Expiry: 12/31/2015
Lot# : DN10356, Expiry: 12/31/2015
Lot# : DN10811, Expiry: 2/29/2016
Lot# : DN10812, Expiry: 2/29/2016
Lot# DN10830, Expiry: 2/29/2016
Lot# : DN10874, Expiry: 2/29/2016
Lot# : DN10875, Expiry: 2/29/2016
Lot# : DN10876, Expiry: 2/29/2016
Lot# : DN10890, Expiry: 2/29/2016
Lot# : DN10891, Expiry: 2/29/2016
Lot# : DN10938, Expiry: 3/31/2016
Lot# : DN10956, Expiry: 3/31/2016.

Recall Number: D-1243-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
124,034 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-421-01.

Batch or Lot Expiration Information

Lot# : DM11774, Expiry: 6/30/2015
Lot# : DM13056, Expiry: 10/31/2015
Lot# : DM13117, Expiry: 10/31/2015
Lot# : DM13159, Expiry: 10/31/2015
Lot# : DM13186, Expiry: 10/31/2015
Lot# : DM13187, Expiry: 10/31/2015
Lot# : DM13188, Expiry: 10/31/2015
Lot# : DN10003, Expiry: 11/30/2015
Lot# : DN10045, Expiry: 11/30/2015
Lot# : DN10046, Expiry: 11/30/2015
Lot# : DN10389, Expiry: 1/31/2016
Lot# : DN10412, Expiry: 1/31/2016
Lot# : DN10604, Expiry: 1/31/2016.

Recall Number: D-1244-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
A) 149,924 Bottles and B) 35,012 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-927-01) and B) 500 Count Bottles (NDC: 64679-927-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Batch or Lot Expiration Information

Lot# A)
Lot# : DM10573, Expiry: 4/30/2015
Lot# : DM11531, Expiry: 5/31/2015
Lot# : DM11532, Expiry: 5/31/2015
Lot# : DM11676, Expiry: 6/30/2015
Lot# : DM11677, Expiry: 6/30/2015
Lot# : DM12543, Expiry: 8/31/2015
Lot# : DM13333, Expiry: 11/30/2015
Lot# : DN10272, Expiry: 12/31/2015
Lot# : DN10405, Expiry: 12/31/2015
Lot# : DN10446, Expiry: 1/1/2016. B)
Lot# : DM11122, Expiry: 4/30/2015
Lot# : DM11130, Expiry: 4/30/2015
Lot# : DM11533, Expiry: 5/31/2015
Lot# : DM11674, Expiry: 6/30/2015
Lot# : DM11675, Expiry: 6/30/2015
Lot# : DM12497, Expiry: 8/31/2015
Lot# : DM13336, Expiry: 11/30/2015
Lot# : DN10289, Expiry: 12/31/2015
Lot# : DN10445, Expiry: 1/31/2016
Lot# : DN10816, Expiry: 1/31/2016
Lot# : DN10817, Expiry: 1/31/2016
Lot# : DN10976, Expiry: 2/29/2016.

Recall Number: D-1274-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
68,066 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Zonisamide Capsules, 25 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0945-01.

Batch or Lot Expiration Information

Lot# : LM10763, Expiry: 4/30/2015
Lot# : LM10764, Expiry: 4/30/2015
Lot# : LM10765, Expiry: 4/30/2015
Lot# : LM11142, Expiry: 6/30/2015
Lot# : LM11143, Expiry: 6/30/2015
Lot# : LM11144, Expiry: 6/30/2015
Lot# : LM11255, Expiry: 7/31/2015
Lot# : LM11256, Expiry: 7/31/2015
Lot# : LM11265, Expiry: 7/31/2015
Lot# : LM11542, Expiry: 8/31/2015
Lot# : LM11543, Expiry: 8/31/2015
Lot# : LN10197, Expiry: 12/31/2015
Lot# : LN10198, Expiry: 12/31/2015
Lot# : LN10199, Expiry: 12/31/2015
Lot# : LN10200, Expiry: 12/31/2015
Lot# : LN10202, Expiry: 12/31/2015
Lot# : LN10203, Expiry: 12/31/2015
Lot# : LN10395, Expiry: 1/31/2016
Lot# : LN10396, Expiry: 1/31/2016
Lot# : LN10531, Expiry: 2/29/2016
Lot# : LN10532, Expiry: 2/29/2016
Lot# : LN10533, Expiry: 2/29/2016
Lot# : LN10534, Expiry: 2/29/2016
Lot# : LN10796, Expiry: 2/29/2016
Lot# : LN10942, Expiry: 4/30/2016.

Recall Number: D-1255-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
A) 146,959 Bottles, B) 73,445 Bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles (NDC: 64679-422-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Batch or Lot Expiration Information

Lot# A)
Lot# : DM11421, Expiry: 5/31/2015
Lot# : DM12956, Expiry: 10/31/2015
Lot# : DM12957, Expiry: 10/31/2015
Lot# : DM12963, Expiry: 10/31/2015
Lot# : DM13242, Expiry: 11/30/2015
Lot# : DM13243, Expiry: 11/30/2015
Lot# : DM13251, Expiry: 11/30/2015
Lot# : DM13260, Expiry: 11/30/2015
Lot# : DN10138, Expiry: 12/31/2015. B)
Lot# : DM11035, Expiry: 4/30/2015
Lot# : DM11088, Expiry: 4/30/2015
Lot# : DM11389, Expiry: 5/31/2015
Lot# : DM11393, Expiry: 5/31/2015
Lot# : DM11394, Expiry: 5/31/2015
Lot# : DM12632, Expiry: 9/30/2015
Lot# : DM12633, Expiry: 9/30/2015
Lot# : DM12650, Expiry: 9/30/2015
Lot# : DM12651, Expiry: 9/30/2015
Lot# : DM12667, Expiry: 5/31/2015
Lot# : DM12964, Expiry: 10/31/2015
Lot# : DM13086, Expiry: 10/31/2015
Lot# : DM13155, Expiry: 10/31/2015
Lot# : DM13156, Expiry: 10/31/2015
Lot# : DM13157, Expiry: 10/31/2015
Lot# : DM13158, Expiry: 10/31/2015
Lot# : DM13184, Expiry: 10/31/2015
Lot# : DM13206, Expiry: 10/31/2015
Lot# : DM13207, Expiry: 10/31/2015
Lot# : DM13266, Expiry: 11/30/2015
Lot# : DM13267, Expiry: 11/30/2015
Lot# : DM13268, Expiry: 11/30/2015
Lot# : DM13283, Expiry: 11/30/2015
Lot# : DM13325, Expiry: 11/30/2015
Lot# : DN10058, Expiry: 12/31/2015
Lot# : DN10059; Expiry: 12/31/2015
Lot# : DN10060, Expiry: 12/31/2015
Lot# : DN10061, Expiry: 12/31/2015
Lot# : DN10062, Expiry: 12/31/2015
Lot# : DN10307, Expiry: 12/31/2015
Lot# : DN10308, Expiry: 12/31/2015
Lot# : DN10324, Expiry: 12/31/2015
Lot# : DN10346, Expiry: 12/31/2015
Lot# : DN10809, Expiry: 2/29/2016
Lot# : DN10810, Expiry: 2/29/2016
Lot# : DN10840, Expiry: 2/29/2016
Lot# : DN10877, Expiry: 2/29/2016
Lot# : DN10878, Expiry: 2/29/2016
Lot# : DN10904, Expiry: 2/29/2016
Lot# : DN10905, Expiry: 2/29/2016
Lot# : DN10921, Expiry: 2/29/2016
Lot# : DN10942, Expiry: 3/31/2016
Lot# : DN10943, Expiry: 3/31/2016
Lot# : DN10972, Expiry: 3/31/2016.

Recall Number: D-1267-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
1,002 Drums

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0972-00.

Batch or Lot Expiration Information

Lot# : LM10826, Expiry: 5/31/2015
Lot# : LM10999, Expiry: 5/31/2015
Lot# : LM11016, Expiry: 6/30/2015
Lot# : LM11032, Expiry: 6/30/2015
Lot# : LM11038, Expiry: 6/30/2015
Lot# : LM11087, Expiry: 6/30/2015
Lot# : LM11149, Expiry: 4/30/2015
Lot# : LM11156, Expiry: 4/30/2015
Lot# : LM11615, Expiry: 8/31/2015
Lot# : LN10195, Expiry: 12/31/2015
Lot# : LN10323, Expiry: 12/31/2015
Lot# : LN10500, Expiry: 1/31/2016
Lot# : LN10507, Expiry: 1/31/2016
Lot# : LN10514, Expiry: 2/29/2016
Lot# : LN10555, Expiry: 2/29/2016
Lot# : LN10556, Expiry: 2/29/2016
Lot# : LN10565, Expiry: 2/29/2016
Lot# : LN10784, Expiry: 3/31/2016
Lot# : LN10788, Expiry: 3/31/2016
Lot# : LN10831, Expiry: 3/31/2016
Lot# : LN10839, Expiry: 3/31/2016
Lot# : LN10846, Expiry: 3/31/2016
Lot# : LN10856, Expiry: 3/31/2016
Lot# : LN10884, Expiry: 3/31/2016
Lot# : LN10916, Expiry: 4/30/2016
Lot# : LN10931, Expiry: 4/30/2016
Lot# : LN10934, Expiry: 4/30/2016
Lot# : LN11067, Expiry: 5/31/2016
Lot# : LN11072, Expiry: 5/31/2016.

Recall Number: D-1258-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
A) 133,920 Bottles, B) 6705 Bottles, and C) 137,659 Bottles.

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Lisinopril Tablets USP, 10 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-929-01), B) 500 Count Bottles (NDC: 64679-929-05), and C) 1000 Count Bottles (NDC: 64679-929-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Batch or Lot Expiration Information

Lot# A)
Lot# : DM11197, Expiry: 4/30/2015
Lot# : DM11202, Expiry: 4/30/2015
Lot# : DM11641, Expiry: 6/30/2015
Lot# : DM12237, Expiry: 8/31/2015
Lot# : DM12238, Expiry: 8/31/2015
Lot# : DM12285, Expiry: 8/31/2015
Lot# : DN10176, Expiry: 12/31/2015
Lot# : DN10636, Expiry: 1/31/2016
Lot# : DN10869, Expiry: 2/29/2016. B)
Lot# : DM11646, Expiry: 6/30/2015
Lot# : DM12364, Expiry: 8/31/2015. C)
Lot# : DM11136, Expiry: 4/30/2015
Lot# : DM11137, Expiry: 4/30/2015
Lot# : DM11142, Expiry: 4/30/2015
Lot# : DM11150, Expiry: 4/30/2015
Lot# : DM11176, Expiry: 4/30/2015
Lot# : DM11212, Expiry: 4/30/2015
Lot# : DM11213, Expiry: 5/31/2015
Lot# : DM11214, Expiry: 5/31/2015
Lot# : DM11222, Expiry: 5/31/2015
Lot# : DM11223, Expiry: 5/31/2015
Lot# : DM11270, Expiry: 5/31/2015
Lot# : DM11277, Expiry: 5/31/2015
Lot# : DM11278, Expiry: 5/31/2015
Lot# : DM11289, Expiry: 5/31/2015
Lot# : DM11290, Expiry: 5/31/2015
Lot# : DM11291, Expiry: 5/31/2015
Lot# : DM11322, Expiry: 5/31/2015
Lot# : DM11499, Expiry: 5/31/2015
Lot# : DM11538, Expiry: 5/31/2015
Lot# : DM11539, Expiry: 5/31/2015
Lot# : DM11540, Expiry: 5/31/2015
Lot# : DM11541, Expiry: 5/31/2015
Lot# : DM11542, Expiry: 5/31/2015
Lot# : DM11543, Expiry: 5/31/2015
Lot# : DM11601, Expiry: 6/30/2015
Lot# : DM11602, Expiry: 6/30/2015
Lot# : DM11617, Expiry: 6/30/2015
Lot# : DM11623, Expiry: 6/30/2015
Lot# : DM11624, Expiry: 6/30/2015
Lot# : DM11825, Expiry: 6/30/2015
Lot# : DM11826, Expiry: 6/30/2015
Lot# : DM11831, Expiry: 6/30/2015
Lot# : DM11875, Expiry: 6/30/2015
Lot# : DM11876, Expiry: 6/30/2015
Lot# : DM11877, Expiry: 6/30/2015
Lot# : DM11878, Expiry: 6/30/2015:
Lot# : DM11883, Expiry: 6/30/2015
Lot# : DM11918, Expiry: 6/30/2015
Lot# : DM11919, Expiry: 6/30/2015
Lot# : DM11922, Expiry: 7/31/2015
Lot# : DM11923, Expiry: 7/31/2015
Lot# : DM11962, Expiry: 7/31/2015
Lot# : DM11963, Expiry: 7/31/2015
Lot# : DM12248, Expiry: 8/31/2015
Lot# : DM12249, Expiry: 8/31/2015
Lot# : DM12263, Expiry: 8/31/2015:
Lot# : DM12306, Expiry: 8/31/2015
Lot# : DM12317, Expiry: 8/31/2015
Lot# : DM12349, Expiry: 8/31/2015
Lot# : DM12350, Expiry: 8/31/2015
Lot# : DM12351, Expiry: 8/31/2015
Lot# : DM12388, Expiry: 8/31/2015
Lot# : DM12389, Expiry: 8/31/2015
Lot# : DM13100, Expiry: 9/30/2015
Lot# : DM13052, Expiry: 9/30/2015
Lot# : DM13053, Expiry: 9/31/2015
Lot# : DM13101, Expiry: 9/30/2015
Lot# : DM13354, Expiry: 9/30/2015
Lot# : DN10148, Expiry: 11/30/2015
Lot# : DN10152, Expiry: 11/30/2015
Lot# : DN10154, Expiry: 12/31/2015
Lot# : DN10155, Expiry: 12/31/2015
Lot# : DN10175, Expiry: 12/31/2015
Lot# : DN10180; Expiry: 12/31/2015
Lot# : DN10185, Expiry: 12/31/2015
Lot# : DN10195, Expiry: 12/31/2015
Lot# : DN10204, Expiry: 12/31/2015
Lot# : DN10213, Expiry: 12/31/2015
Lot# : DN10594, Expiry: 1/31/2016
Lot# : DN10595, Expiry: 1/31/2016
Lot# : DN10606, Expiry: 1/31/2016
Lot# : DN10607, Expiry: 1/31/2016
Lot# : DN10630, Expiry: 1/31/2016
Lot# : DN10637, Expiry: 1/31/2016
Lot# : DN10638, Expiry: 1/31/2016
Lot# : DN10767, Expiry: 2/29/2016
Lot# : DN10768, Expiry: 2/29/2016
Lot# : DN10769, Expiry: 9/30/2015
Lot# : DN10777, Expiry: 2/29/2016
Lot# : DN10782, Expiry: 2/29/2016
Lot# : DN10783, Expiry: 1/31/2016
Lot# : DN10784, Expiry: 2/29/2016
Lot# : DN10834, Expiry: 2/29/2016
Lot# : DN10835, Expiry: 2/29/2016.

Recall Number: D-1253-2015

Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Initiated
04-22-2015
Reported
07-29-2015
Quantity
407,958 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
71104
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.
Wockhardt Usa 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.
U.S. Nationwide including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-09-2018
Product Description About Product Description
Full technical description of the product.
Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 Count Bottles (NDC: 64679-516-02) and B) 500 Count Bottles (NDC: 64679-516-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Batch or Lot Expiration Information

Lot# A)
Lot# : LN10896, Expiry: 4/30/2015
Lot# : LN10901, Expiry: 4/30/2015
Lot# :LN10902, Expiry: 4/30/2015
Lot# : LN10903, Expiry: 4/30/2015
Lot# : LN11020, Expiry: 5/31/2015
Lot# : LN11021, Expiry: 5/31/2015
Lot# : LN11055, Expiry: 5/31/2015
Lot# : LN11056, Expiry: 5/31/2015
Lot# : LN11149, Expiry: 5/31/2015
Lot# : LN11150, Expiry: 5/31/2015
Lot# : LN11267, Expiry: 6/30/2015
Lot# : LN11357, Expiry: 7/31/2015
Lot# : LN11387, Expiry: 8/31/2015
Lot# : LN11421, Expiry: 9/30/2015. B)
Lot# : LN10808, Expiry: 4/30/2015
Lot# : LN11083, Expiry: 5/31/2015
Lot# : LN11084, Expiry: 5/31/2015
Lot# : LN11085, Expiry: 5/31/2015
Lot# : LN11089, Expiry: 5/31/2015
Lot# : LN11109, Expiry: 5/31/2015
Lot# : LN11110, Expiry: 5/31/2015
Lot# : LN11120, Expiry: 5/31/2015
Lot# : LN11121, Expiry: 5/31/2015
Lot# : LN11186, Expiry: 5/31/2015
Lot# : LN11187, Expiry: 6/30/2015
Lot# : LN11188, Expiry: 6/30/2015
Lot# : LN11206, Expiry: 6/30/2015
Lot# : LN11226, Expiry: 6/30/2015
Lot# : LN11227, Expiry: 6/30/2015
Lot# : LN11233, Expiry: 6/30/2015
Lot# : LN11251, Expiry: 6/30/2015
Lot# : LN11257, Expiry: 6/30/2015
Lot# : LN11262, Expiry: 7/31/2015
Lot# : LN11263, Expiry:7/31/2015
Lot# : LN11274, Expiry: 7/31/2015
Lot# : LN11288, Expiry: 7/31/2015
Lot# : LN11370; Expiry: 8/31/2015
Lot# : LN11371, Expiry: 8/31/2015
Lot# : LN11378, Expiry: 8/31/2015
Lot# : LN11384, Expiry: 8/31/2015
Lot# : LN11400, Expiry: 9/30/2015
Lot# : LN11402, Expiry: 9/30/2015
Lot# : LN11406, Expiry: 9/30/2015
Lot# : LN11412, Expiry: 9/30/2015
Lot# : LN11416, Expiry: 9/30/2015
Lot# : LN11428, Expiry: 9/30/2015.