Medications & Supplements/Prescription Drugs

H J Harkins Company Inc dba Pharma Pac: Neomycin/Polymyxin/Dexamethasone Ophthalmic Ointment Recalled for CGMP Deviations

Agency Publication Date: July 31, 2019

Summary

H J Harkins Company Inc dba Pharma Pac is recalling 97 tubes of Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment (3.5g). The recall was initiated due to deviations from Current Good Manufacturing Practice (CGMP) requirements, specifically insufficient quality assurance controls over critical systems in the manufacturing facility. This prescription medication is used for eye conditions and was distributed in California.

Risk

Insufficient quality controls in a manufacturing facility can compromise the sterility, purity, or potency of the ointment. Using a contaminated or improperly formulated ophthalmic product could lead to ineffective treatment or potential eye irritation or infection.

What You Should Do

Check your prescription medication packaging for 'Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment' in 3.5 g tubes with NDC 52959-0407-01.
Identify if your product matches one of the following Lot numbers and Expiration dates: NPD10RP (Exp 08/19), NPD11RP (Exp 09/19), NPD12RP (Exp 11/19), NPD13RP (Exp 02/20), NPD14RP (Exp 02/20), NPD15RP (Exp 05/20), NPD16RP (Exp 06/20), NPD17RP (Exp 01/21), or NPD18RP (Exp 02/21).
If you have an affected product, contact your healthcare provider or pharmacist immediately for guidance on an alternative treatment.
Return any unused ointment to the pharmacy where you purchased it for a refund.
Contact H J Harkins Company Inc dba Pharma Pac for further instructions regarding this recall.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment (3.5 g tube)

Model:

NDC 52959-0407-01

Lot Numbers:

NPD10RP (Exp 08/19)

NPD11RP (Exp 09/19)

NPD12RP (Exp 11/19)

NPD13RP (Exp 02/20)

NPD14RP (Exp 02/20)

NPD15RP (Exp 05/20)

NPD16RP (Exp 06/20)

NPD17RP (Exp 01/21)

NPD18RP (Exp 02/21)

Date Ranges: Exp 08/19, Exp 09/19, Exp 11/19, Exp 02/20, Exp 05/20, Exp 06/20, Exp 01/21, Exp 02/21

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83339

Status: Resolved

Manufacturer: H J Harkins Company Inc dba Pharma Pac

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 97 boxes

Distributed To: California

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.

Summary

What You Should Do

Check your prescription medication packaging for 'Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment' in 3.5 g tubes with NDC 52959-0407-01.

Identify if your product matches one of the following Lot numbers and Expiration dates: NPD10RP (Exp 08/19), NPD11RP (Exp 09/19), NPD12RP (Exp 11/19), NPD13RP (Exp 02/20), NPD14RP (Exp 02/20), NPD15RP (Exp 05/20), NPD16RP (Exp 06/20), NPD17RP (Exp 01/21), or NPD18RP (Exp 02/21).

If you have an affected product, contact your healthcare provider or pharmacist immediately for guidance on an alternative treatment.

Return any unused ointment to the pharmacy where you purchased it for a refund.

Contact H J Harkins Company Inc dba Pharma Pac for further instructions regarding this recall.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment (3.5 g tube)

Model:

NDC 52959-0407-01

Lot Numbers:

NPD10RP (Exp 08/19)

NPD11RP (Exp 09/19)

NPD12RP (Exp 11/19)

NPD13RP (Exp 02/20)

NPD14RP (Exp 02/20)

NPD15RP (Exp 05/20)

NPD16RP (Exp 06/20)

NPD17RP (Exp 01/21)

NPD18RP (Exp 02/21)

Date Ranges: Exp 08/19, Exp 09/19, Exp 11/19, Exp 02/20, Exp 05/20, Exp 06/20, Exp 01/21, Exp 02/21