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 Solu

FDA recall notice · announced July 31, 2019 · Preferred Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Reason for recall

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

Notes

Distribution: CA, FL
Lot/code information: Lot #: L2117Q, Batch: 12211717, Exp. 09/2019; F2818H, Batch: 06281808, Exp. 11/2019; B1819T, Batch: B1819T001 to B1819T048 (Inclusive), Exp. 05/2020.
Quantity: 171 tubes
Status: Terminated
Products in this recall event:
- 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, LL (D-1491-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.