Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone Recalled by H J Harkins Company Inc dba Pharma Pac Due to CGMPs Deviations: Insufficient Quality Assurance controls over critical...

Date: July 12, 2019
Company: H J Harkins Company Inc dba Pharma Pac
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact H J Harkins Company Inc dba Pharma Pac directly.

Affected Products

Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment, 3.5 g tube, Rx only, Manufactured for H.J. Harkins Company, Inc. dba Pharma Pac by Perrigo Co, Allegan, MI 49010, NDC 52959-0407-01

Quantity: 97 boxes

Why Was This Recalled?

CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.

Where Was This Sold?

Distributed in California

About H J Harkins Company Inc dba Pharma Pac

H J Harkins Company Inc dba Pharma Pac has 9 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report