Reported Aug 7, 2019 · Terminated

Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophthalmic Ointment, 3.5 g tube, Rx only,…

H J Harkins Company Inc. dba Pharma Pac

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: H J Harkins Company Inc dba Pharma Pac · 1400 W Grand Ave Ste F · Grover Beach, CA · 93433-4221

Is this the product you have?

  • 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
Lot codes and dates
    • Lot #: 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
Amount recalled
97 boxes

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 5, 2023 · Data as of Sep 19, 8:02 PM UTC

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