D-1580-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 7, 2019
- Initiation Date
- July 12, 2019
- Termination Date
- June 5, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 97 boxes
Product Description
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
Reason for Recall
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Distribution Pattern
Distributed in California
Code Information
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