Recalls / Class II
Class IID-1580-2019
Product
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
- Affected lot / code info
- 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
Why it was recalled
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Recalling firm
- Firm
- H J Harkins Company Inc dba Pharma Pac
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1400 W Grand Ave Ste F, N/A, Grover Beach, California 93433-4221
Distribution
- Quantity
- 97 boxes
- Distribution pattern
- Distributed in California
Timeline
- Recall initiated
- 2019-07-12
- FDA classified
- 2019-07-31
- Posted by FDA
- 2019-08-07
- Terminated
- 2023-06-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1580-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.