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 #: NPD10RPExp 08/19NPD11RPExp 09/19NPD12RPExp 11/19NPD13RPExp 02/20NPD14RPExp 02/20NPD15RPExp 05/20NPD16RPExp 06/20NPD17RPExp 01/21NPD18RPExp 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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