Multi-event October 2023 FDA Recall Drug by Pine Pharmaceuticals, Llc

This Multi-event Class II drug recall was voluntarily initiated by Pine Pharmaceuticals, Llc on October 2, 2023 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0061-2024 TERMINATED D-0051-2024 TERMINATED D-0065-2024 TERMINATED D-0058-2024 TERMINATED D-0053-2024 TERMINATED D-0064-2024 TERMINATED D-0057-2024 TERMINATED D-0062-2024 TERMINATED D-0063-2024 TERMINATED D-0054-2024 TERMINATED D-0050-2024 TERMINATED D-0056-2024 TERMINATED D-0052-2024 TERMINATED D-0059-2024 TERMINATED D-0060-2024 TERMINATED D-0055-2024 TERMINATED

Recall Number: D-0061-2024

Reason for Recall
Lack of Assurance of Sterility
Initiated
10-02-2023
Reported
10-25-2023
Quantity
130

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93154
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.
Pine Pharmaceuticals, LLC
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.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-15-2024
Product Description About Product Description
Full technical description of the product.
Calcium chloride Solution for Intravenous Injection, 20 mg/mL, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Batch or Lot Expiration Information

Lot# : 70101, Exp. Date 1/17/2024

Recall Number: D-0051-2024

Reason for Recall
Lack of Assurance of Sterility
Initiated
10-02-2023
Reported
10-25-2023
Quantity
26 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93154
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.
Pine Pharmaceuticals, LLC
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.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-15-2024
Product Description About Product Description
Full technical description of the product.
Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Batch or Lot Expiration Information

Lot# : 69985, exp. date 11/15/2023

Recall Number: D-0065-2024

Reason for Recall
Lack of Assurance of Sterility
Initiated
10-02-2023
Reported
10-25-2023
Quantity
136 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93154
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.
Pine Pharmaceuticals, LLC
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.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-15-2024
Product Description About Product Description
Full technical description of the product.
Foscarnet Sodium 2.4mg/0.1 mL solution for injection, 0.2 mL single-dose Staclear Luer Slip Syringe, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Batch or Lot Expiration Information

Lot# : 68680, Exp. Date 12/4/2023

Recall Number: D-0058-2024

Reason for Recall
Lack of Assurance of Sterility
Initiated
10-02-2023
Reported
10-25-2023
Quantity
2176 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93154
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.
Pine Pharmaceuticals, LLC
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.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-15-2024
Product Description About Product Description
Full technical description of the product.
Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Batch or Lot Expiration Information

Lot# : 67623, Exp. Date 10/15/2023; 67919, Exp. Date 10/29/2023; 68917, Exp. Date 12/16/2023; 69079, Exp. Date 12/23/2023; 69120, Exp. Date 12/24/2023

Recall Number: D-0053-2024

Reason for Recall
Lack of Assurance of Sterility
Initiated
10-02-2023
Reported
10-25-2023
Quantity
128 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93154
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.
Pine Pharmaceuticals, LLC
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.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-15-2024
Product Description About Product Description
Full technical description of the product.
Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Batch or Lot Expiration Information

Lot# : 69802, Exp. Date 02/28/2024

Recall Number: D-0064-2024

Reason for Recall
Lack of Assurance of Sterility
Initiated
10-02-2023
Reported
10-25-2023
Quantity
860 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93154
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.
Pine Pharmaceuticals, LLC
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.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-15-2024
Product Description About Product Description
Full technical description of the product.
Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Batch or Lot Expiration Information

Lot# : 67808, Exp. Date 10/23/2023

Recall Number: D-0057-2024

Reason for Recall
Lack of Assurance of Sterility
Initiated
10-02-2023
Reported
10-25-2023
Quantity
4972 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93154
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.
Pine Pharmaceuticals, LLC
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.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-15-2024
Product Description About Product Description
Full technical description of the product.
Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Batch or Lot Expiration Information

Lot# : 67918, Exp. Date 10/29/2023; 68033, Exp. Date 11/4/2023; 68515, Exp. Date 11/26/2023; 68528, Exp. Date 11/27/2023; 68618, Exp. Date 12/2/2023; 68651, Exp. Date 12/3/2023; 68767, Exp. Date 12/9/2023; 68829, Exp. Date 12/11/2023; 69820, Exp. Date 1/9/2024; 70733, Exp. Date 2/19/2024; 71068, Exp. Date 3/9/2024; 67345, Exp. Date 10/3/2023

Recall Number: D-0062-2024

Reason for Recall
Lack of Assurance of Sterility
Initiated
10-02-2023
Reported
10-25-2023
Quantity
1598 droppers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93154
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.
Pine Pharmaceuticals, LLC
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.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-15-2024
Product Description About Product Description
Full technical description of the product.
Lidocaine HCl 4% ophthalmic solution, 3 mL single-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Batch or Lot Expiration Information

Lot# : 67443, Exp. Date 10/8/2023; 68775, Exp. Date 12/9/2023

Recall Number: D-0063-2024

Reason for Recall
Lack of Assurance of Sterility
Initiated
10-02-2023
Reported
10-25-2023
Quantity
662 dropper

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93154
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.
Pine Pharmaceuticals, LLC
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.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-15-2024
Product Description About Product Description
Full technical description of the product.
Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Batch or Lot Expiration Information

Lot# : 67659, Exp. Date 10/16/2023; 70316, Exp. Date 1/30/2024

Recall Number: D-0054-2024

Reason for Recall
Lack of Assurance of Sterility
Initiated
10-02-2023
Reported
10-25-2023
Quantity
881 pre-filled syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93154
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.
Pine Pharmaceuticals, LLC
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.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-15-2024
Product Description About Product Description
Full technical description of the product.
Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Batch or Lot Expiration Information

Lot# : 70363, Exp. Date 03/20/2024

Recall Number: D-0050-2024

Reason for Recall
Lack of Assurance of Sterility
Initiated
10-02-2023
Reported
10-25-2023
Quantity
2862 Syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93154
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.
Pine Pharmaceuticals, LLC
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.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-15-2024
Product Description About Product Description
Full technical description of the product.
Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Batch or Lot Expiration Information

Lot# : 68622, 68620 Exp. Date 10/3/2023; 68632 Exp. Date 10/4/2023; 68699, 68704, 68706 Exp. Date 10/6/2023; 68726, 68740 Exp. Date 10/7/2023; 68784 Exp. Date 10/11/2023; 68843, 68861, Exp. Date 10/13/2023; 68789,68822 Exp. Date 10/12/2023; 68914 Exp. Date 10/17/2023; 68952, 68954, 68980 Exp. Date 10/18/2023; 69105 Exp. Date 10/25/2023; 69731 Exp. Date 11/7/2023; 69991 Exp. Date 11/15/2023;70142 Exp. Date 11/22/2023; 70233 Exp. Date 11/28/2023; 70297, 70264, 70291, 70300 Exp. Date 11/30/2023; 70355 Exp. Date 12/5/2023; 70516, 70513 Exp. Date 12/12/2023;;70659, 70664 Exp. Date 12/19/2023; 70700 Exp. Date 12/20/2023; 68912, Exp. Date 10/17/2023; 69071, Exp. Date 10/24/2023; 69725, Exp. Date 10/31/2023; 69749, Exp. Date 11/1/2023; 69961, Exp. Date 11/14/2023; 70112, Exp. Date 11/21/2023; 70228, Exp. Date 11/28/2023; 70353, Exp. Date 12/5/2023; 70403, Exp. Date 12/9/2023; 70513, Exp. Date 2/12/2023; 70569, 70570, 70579, 70571, 70572,70573, 70585, 70503 Exp. Date 12/14/2023; 70692, Exp. Date 12/20/2023; 68912, Exp. Date 10/17/2023; 69071, Exp. Date 10/24/2023; 69725, Exp. Date 10/31/2023; 69749, Exp. Date 1/7/2023; 69961, Exp. Date 11/14/2023; 70112, Exp. Date 11/21/2023; 70228, Exp. Date 11/28/2023; 70353, Exp. Date 12/5/2023; 70 692, Exp. Date 12/20/2023, 67538, Exp. Date 10/11/2023; 68535, Exp. Date 10/4/2023; 68611, 68613 Exp. Date 10/3/2023; 68612, 68633, 68637 Exp. Date 10/4/2023; 68638, 68673, 68674,68675, Exp. Date 10/5/2023; 68634, 68699, 68700, 68701, 68702, 68709 Exp. Date 10/6/2023; 68703, 68708, 68728, 68729, 68736, 68737, 68738, 68739, Exp. Date 10/7/2023; 68647, 68757, 68758, 68759, Exp. Date 10/10/2023; 68784, 68785, 68786, 68787, 68788, Exp. Date 10/11/2023; 68821, 68823, 68824, Exp. Date 10/12/2023; 68896, 68897, 68843, 68844, 68850, 68851, 68852, 10/13/2023; 68853 68877, 68878, 68879, 68880, 68886, 68890, 68891 Exp. Date 10/14/2023; 68913, 68915, 68923, Exp. Date 10/17/2023; 68922, 68953,68976, 68980, Exp. Date 10/18/2023; 68977, 68978,68979, 68981, Exp. Date 10/19/2023; 68959,68982, 69016, 69017, 69019, 69012 Exp. Date 10/20/2023; 69018, 69047, 69048, 69049, 69050, 69051, 69052, 69056, 68983, 69042, Exp. Date 10/21/2023; 69072, 69073, 69074, 69075, Exp. Date 10/24/2023; 69102, 69103, 69104, 69105, 69109, Exp. Date 10/25/2023; 69129, 69127, 69077 Exp. Date 10/26/2023; 69142, 69128, Exp. Date 10/27/2023; 69130, 69101, 69131, 69132, 69143, 69144, 69166, 69167, 69168, 69169, 69170, 69171, Exp. Date 10/28/2023; 69726, 69727, Exp. Date 10/31/2023;69746, 69748, 69750, Exp. Date 11/2/2023; 69754, 69755, 69768, 69770, Exp. Date 11/3/2023; 69779, 69751, 69745, 69780, 69781, 69782, 69783, 69784, 69793, Exp. Date 11/4/2023; 69794, 6974, ; 69841, Exp. Date 11/8/2023; 69865, 69866, 69863, 69867, 69796, 69872 Exp. Date 11/9/2023; 69890, 69892,69893, 69894, 69895, 69896, 69897, Exp. Date 11/10/2023; 69928, 69929, 69930,69931,69932, 69933, 69928, 69950, Exp. Date 11/11/2023; 69964, 69868, Exp. Date 11/14/2023; 69965, 69987, 69988, 69990, Exp. Date 11/15/2023; 70031, 70032, 70033, 69963, 70034, Exp. Date 11/16/2023; 70066,70067, Exp. Date 11/17/2023; 69998,70011,69962, 70094, 70095, 69864, 70093 Exp. Date 11/18/2023; 70035, 70113, 70114, 70115, Exp. Date 11/21/2023; 70116, 70138, 70139, 70140, 70147, Exp. Date 11/22/2023; 70163, 70164, 70165, 70166, 70167, 70168, Exp. Date 11/23/2023; 70191, 70193,70194, 70195, 70196, 70197, 70198, 70204, Exp. Date 11/24/2023; 70208, 70211, 70212, 70213, 70214, 70220, 70218, Exp. Date 11/25/2023; 70229, 70231, 70232, 70234, Exp. Date 11/28/2023; 70254, 70255, 70256, 70257, 70261, 70262, 70263, 70277, 70258, 70275 Exp. Date 11/29/2023; 70265, 70314, 70315, 70259,70299 Exp. Date 12/1/2023; 70325, 70326, 70333,70338, 70341 Exp. Date 12/2/2023; 70358, Exp. Date 12/5/2023; 70397, 70398, 70399, 70399, 70409, 70410, 70406, 70404 Exp. Date 12/6/2023; 70324, 70339, 70445, 70450, Exp. Date 12/7/2023; 70462, 70463, 70465, 70466, 70467, Exp. Date 12/8/2023; 70494, 70495, 70497, 70493, 70497, 70501, 70422 Exp. Date 12/9/2023; 70523, 70419, 70514, Exp. Date 12/12/2023;70544, 70549, 70552, 70553, Exp. Date 12/13/2023; 70605,70606, 70340, 70608,70609, 70613, 70619 Exp. Date 12/15/2023; 70635, 70636, Exp. Date 12/16/2023; 70660, 70661, 70662, 70663, 12/19/2023; 70672, 70693, 70694,70695,70696, 70702, Exp. Date 12/20/2023; 70726, 70727, 70728, 70729, 70730, 70744, 70731, Exp. Date 12/21/2023; 70759, 70760, 70762, 70763, Exp. Date 12/22/2023; 70786,70791, 70788, 70789 Exp. Date 12/23/2023; 70835, 70787, 70790, Exp. Date 12/26/2023; 70852, 70853, 70860, 70833 Exp. Date 12/27/2023; 70868, 70869, 70870, 70871, 70874, Exp. Date 12/28/2023; 70832, 70851, Exp. Date 1/4/2024.

Recall Number: D-0056-2024

Reason for Recall
Lack of Assurance of Sterility
Initiated
10-02-2023
Reported
10-25-2023
Quantity
2484 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93154
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.
Pine Pharmaceuticals, LLC
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.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-15-2024
Product Description About Product Description
Full technical description of the product.
Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0.1mL) Syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Batch or Lot Expiration Information

Lot# : 67480, Exp. Date 10/9/2023; 68640,Exp. Date 12/3/2023; 68769, Exp. Date 12/9/2023; 68760, Exp. Date 12/10/2023; 68925, Exp. Date 12/16/2023;70119, Exp. Date 1/20/2024

Recall Number: D-0052-2024

Reason for Recall
Lack of Assurance of Sterility
Initiated
10-02-2023
Reported
10-25-2023
Quantity
201 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93154
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.
Pine Pharmaceuticals, LLC
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.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-15-2024
Product Description About Product Description
Full technical description of the product.
Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Batch or Lot Expiration Information

Lot# : 69986, Exp. Date 11/15/2023

Recall Number: D-0059-2024

Reason for Recall
Lack of Assurance of Sterility
Initiated
10-02-2023
Reported
10-25-2023
Quantity
9673 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93154
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.
Pine Pharmaceuticals, LLC
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.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-15-2024
Product Description About Product Description
Full technical description of the product.
Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Batch or Lot Expiration Information

Lot# : 67849, Exp. Date 10/25/2023; 67887, Exp. Date 10/28/2023; 68260, Exp. Date 11/14/2023; 68534, Exp. Date 11/27/2023; 68816, Exp. Date 12/12/2023; 69046, Exp. Date 12/20/2023; 69971, Exp. Date 1/13/2024

Recall Number: D-0060-2024

Reason for Recall
Lack of Assurance of Sterility
Initiated
10-02-2023
Reported
10-25-2023
Quantity
1693 droppers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93154
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.
Pine Pharmaceuticals, LLC
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.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-15-2024
Product Description About Product Description
Full technical description of the product.
TPC Drops (tropicamide 1%- phenylephrine 2.5%- cyclopentolate HCl 1% ophthalmic solution, 5 mL droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Batch or Lot Expiration Information

Lot# : 68184, Exp. Date 10/9/2023; 68623, Exp. Date 11/2/2023

Recall Number: D-0055-2024

Reason for Recall
Lack of Assurance of Sterility
Initiated
10-02-2023
Reported
10-25-2023
Quantity
2181 droppers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93154
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.
Pine Pharmaceuticals, LLC
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.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-15-2024
Product Description About Product Description
Full technical description of the product.
Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Batch or Lot Expiration Information

Lot# : 67008, Exp. Date 10/04/2023; 67685, Exp. Date 10/21/2023; 67853, Exp. Date 10/25/2023; 69967, Exp. Date 01/13/2024