Recalls / Class II
Class IID-1491-2019
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.
- Affected 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.
Why it was recalled
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Recalling firm
- Firm
- Preferred Pharmaceuticals, Inc
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1250 N Lakeview Ave Ste O, N/A, Anaheim, California 92807-1801
Distribution
- Quantity
- 171 tubes
- Distribution pattern
- CA, FL
Timeline
- Recall initiated
- 2019-07-18
- FDA classified
- 2019-07-22
- Posted by FDA
- 2019-07-31
- Terminated
- 2023-04-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1491-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.