Drug product
Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg Ophthalmic Ointment, Pkg Size 3 g Tube, Generic for: Maxitrol, For External Use Only, Rx only, Mfg: Paddock Laboratories, LLC, Preferred Pharmaceuticals, Inc., The Physicians Solutions, Anaheim, CA, NDC 68788-9373-03.
D-1491-2019
Product summary
- Event
- Event 83370
- Status
- Terminated
- Classification
- Class II
- Quantity
- 171 tubes
- Official record key
drug-enforcement:D-1491-2019
Official wording
Reason: CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Code information: Lot #: L2117Q, Batch: 12211717, Exp. 09/2019; F2818H, Batch: 06281808, Exp. 11/2019; B1819T, Batch: B1819T001 to B1819T048 (Inclusive), Exp. 05/2020.
Distribution pattern: CA, FL
Derived failure modes
-
Unknown
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.