Liberty Drug & Surgical: Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.

Agency Publication Date: August 27, 2015

Affected Products

Product: Cyanocobalamin 500 mcg/mL Injectable, 1 mL pre-filled syringe, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05152015@2, Exp 06/29/15

Lot Numbers:

05152015

Product: Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/1 mg/10 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05112015@19, Exp 06/25/15

Lot Numbers:

05112015

Product: Methylcobalamin 5000 mcg/mL Injectable, 2 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05152015@4, Exp 06/29/15

Lot Numbers:

05152015

Product: Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 9 mg/1 mg/0.1 mg/10 mcg/mL, 2 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05192015@17, Exp 07/03/15

Lot Numbers:

05192015

Product: Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/2 mg/20 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05282015@7, Exp 07/13/15

Lot Numbers:

05282015

Product: Papaverine/Phentolamine/PGE-1 Injectable, 10 mg/0.6 mg/10 mcg/mL, 2.5 mL vials, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05112015@3, Exp 06/25/15; 06012015@12, Exp 07/17/15

Lot Numbers:

05112015

Product: Papaverine/Phentolamine/PGE-1 Injectable, 20.8 mg/1.4 mg/14 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 06042015@9, Exp 07/19/15

Lot Numbers:

06042015

Product: Vancomycin 25 mg/mL Opthalmic Solution, packaged in a) 10 mL bottle and b) 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: a) 06042015@15, Exp 06/18/15; 06052015@3, Exp 06/19/15; b) 06082015@21, Exp 06/22/15

Product: Doxcycline/0.9% NaCl 150 mg/150 mL IV, 150 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05122015@13, Exp 06/15/15; 05262015@17, 06082015@11, Exp 07/06/15

Lot Numbers:

05122015

Product: Tobramycin 14 mg/mL Ophthalmic Solution, 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 06082015@20, Exp 06/22/15

Lot Numbers:

06082015

Product: Doxycycline/0.9 % NaCl 100 mg/100 mL IV, 100 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05142015@21, 05192015@22, 05282015@16, 06022015@18, 06102015@16, Exp 07/06/15

Lot Numbers:

05142015

Product: 17-Hydroxyprogesterone 250 mg/mL Injectable, 5 mL multi-dose vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 03182015@8, Exp 07/31/15; 05112015@7, Exp 09/24/15

Lot Numbers:

03182015

Product: Hydroxocobalamin (Preserved) 10,000 mcg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 06082015@5, Exp 07/24/15

Lot Numbers:

06082015

Product: Papervine/Phentolamine/PGE-1 Injectable, 30 mg/0.5 mg/30 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 06022015@5, Exp 07/17/15

Lot Numbers:

06022015

Product: Doxycycline/0.9% NaCl 150 mg/250 mL IV, 250 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 0513215@12, 05192015@1, 05222015@14, 05222015@15, 05282015@17, 06012015@18, 06022015@19, 06052015@23, Exp 07/06/15

Lot Numbers:

0513215

Product: Dexamethasone 24 mg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05012015@1, Exp 06/15/15; 06022015@14, Exp 07/17/15; 06112015@10, Exp 07/26/15

Lot Numbers:

05012015

Product: Morphine/0.9 % NaCl 1 mg/mL IV, 250 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 06042015@11, Exp 07/19/15; 06102015@3, Exp 07/25/15

Lot Numbers:

06042015

Product: Glycerin (v/v) 72% Injection, 25 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05122015@6, Exp 06/26/15

Lot Numbers:

05122015

Product: Phenol 6% Injectable, 30 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 06032015@16, Exp 07/18/15

Lot Numbers:

06032015

Product: Methadone 10 mg/mL Injection, 10 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05012015@5, Exp 06/16/15; 05152015@10, Exp 06/30/15

Lot Numbers:

05012015

Product: Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 75 mg/2.5 mg/0.1 mg/75 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 04202015@18, Exp 06/04/15; 05192015@16, Exp 07/03/15

Lot Numbers:

04202015

Product: Doxycycline/0.9% NaCl 300 mg/500 mL IV, 500 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05142015@20, Exp 07/06/15; 05282015@15, Exp 07/06/15

Lot Numbers:

05142015

Product: Hydroxocobalamin (Preserved) 1,000 mcg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 06102015@15, Exp 07/25/15

Lot Numbers:

06102015

Product: Lidocaine/Sodium Chloride 0.4%/20% Injectable, 5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05072015@4, Exp 06/21/15

Lot Numbers:

05072015

Product: Methylcobalamin 1,000 mcg/mL Injectable, 1.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05072015@7, Exp 06/21/15

Lot Numbers:

05072015

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 71591

Status: Resolved

Manufacturer: Liberty Drug & Surgical

Manufactured In: United States

Units Affected: 25 products (6 syringes; 2 vials; 5 vials; 4 vials; 2 vials; 4 vials; 2 vials; 3 bottles; 88 bags; 1 bottle; 58 bags; 85 vials; 15 vials; 2 vials; 112 bags; 22 vials; 4 bags; 1 vial; 2 vials; 5 vials; 6 vials; 30 bags; 6 vials; 5 vials; 6 vials)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: Cyanocobalamin 500 mcg/mL Injectable, 1 mL pre-filled syringe, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05152015@2, Exp 06/29/15

Lot Numbers:

05152015

Product: Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/1 mg/10 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05112015@19, Exp 06/25/15

Lot Numbers:

05112015

Product: Methylcobalamin 5000 mcg/mL Injectable, 2 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05152015@4, Exp 06/29/15

Lot Numbers:

05152015

Product: Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 9 mg/1 mg/0.1 mg/10 mcg/mL, 2 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05192015@17, Exp 07/03/15

Lot Numbers:

05192015

Product: Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/2 mg/20 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05282015@7, Exp 07/13/15

Lot Numbers:

05282015

Product: Papaverine/Phentolamine/PGE-1 Injectable, 10 mg/0.6 mg/10 mcg/mL, 2.5 mL vials, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05112015@3, Exp 06/25/15; 06012015@12, Exp 07/17/15

Lot Numbers:

05112015

Product: Papaverine/Phentolamine/PGE-1 Injectable, 20.8 mg/1.4 mg/14 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 06042015@9, Exp 07/19/15

Lot Numbers:

06042015

Product: Vancomycin 25 mg/mL Opthalmic Solution, packaged in a) 10 mL bottle and b) 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: a) 06042015@15, Exp 06/18/15; 06052015@3, Exp 06/19/15; b) 06082015@21, Exp 06/22/15

Product: Doxcycline/0.9% NaCl 150 mg/150 mL IV, 150 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05122015@13, Exp 06/15/15; 05262015@17, 06082015@11, Exp 07/06/15

Lot Numbers:

05122015

Product: Tobramycin 14 mg/mL Ophthalmic Solution, 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 06082015@20, Exp 06/22/15

Lot Numbers:

06082015

Product: Doxycycline/0.9 % NaCl 100 mg/100 mL IV, 100 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05142015@21, 05192015@22, 05282015@16, 06022015@18, 06102015@16, Exp 07/06/15

Lot Numbers:

05142015

Product: 17-Hydroxyprogesterone 250 mg/mL Injectable, 5 mL multi-dose vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 03182015@8, Exp 07/31/15; 05112015@7, Exp 09/24/15

Lot Numbers:

03182015

Product: Hydroxocobalamin (Preserved) 10,000 mcg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 06082015@5, Exp 07/24/15

Lot Numbers:

06082015

Product: Papervine/Phentolamine/PGE-1 Injectable, 30 mg/0.5 mg/30 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 06022015@5, Exp 07/17/15

Lot Numbers:

06022015

Product: Doxycycline/0.9% NaCl 150 mg/250 mL IV, 250 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 0513215@12, 05192015@1, 05222015@14, 05222015@15, 05282015@17, 06012015@18, 06022015@19, 06052015@23, Exp 07/06/15

Lot Numbers:

0513215

Product: Dexamethasone 24 mg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05012015@1, Exp 06/15/15; 06022015@14, Exp 07/17/15; 06112015@10, Exp 07/26/15

Lot Numbers:

05012015

Product: Morphine/0.9 % NaCl 1 mg/mL IV, 250 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 06042015@11, Exp 07/19/15; 06102015@3, Exp 07/25/15

Lot Numbers:

06042015

Product: Glycerin (v/v) 72% Injection, 25 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05122015@6, Exp 06/26/15

Lot Numbers:

05122015

Product: Phenol 6% Injectable, 30 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 06032015@16, Exp 07/18/15

Lot Numbers:

06032015

Product: Methadone 10 mg/mL Injection, 10 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05012015@5, Exp 06/16/15; 05152015@10, Exp 06/30/15

Lot Numbers:

05012015

Product: Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 75 mg/2.5 mg/0.1 mg/75 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 04202015@18, Exp 06/04/15; 05192015@16, Exp 07/03/15

Lot Numbers:

04202015

Product: Doxycycline/0.9% NaCl 300 mg/500 mL IV, 500 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05142015@20, Exp 07/06/15; 05282015@15, Exp 07/06/15

Lot Numbers:

05142015

Product: Hydroxocobalamin (Preserved) 1,000 mcg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 06102015@15, Exp 07/25/15

Lot Numbers:

06102015

Product: Lidocaine/Sodium Chloride 0.4%/20% Injectable, 5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05072015@4, Exp 06/21/15

Lot Numbers:

05072015

Product: Methylcobalamin 1,000 mcg/mL Injectable, 1.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928.

Lot #: 05072015@7, Exp 06/21/15

Lot Numbers:

05072015

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 71591

Status: Resolved

Manufacturer: Liberty Drug & Surgical

Manufactured In: United States