Class II
Terminated
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.
- Company
- Preferred Pharmaceuticals, Inc.
- Recall Initiated
- July 18, 2019
- Posted
- July 31, 2019
- Recall Number
- D-1491-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 171 tubes
- Firm Location
- Anaheim, CA, United States
Reason for Recall
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Distribution
CA, FL
Lot / Code Info
Lot #: L2117Q, Batch: 12211717, Exp. 09/2019; F2818H, Batch: 06281808, Exp. 11/2019; B1819T, Batch: B1819T001 to B1819T048 (Inclusive), Exp. 05/2020.
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