FDA Drug recall D-1491-2019
Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg Ophthalmic Ointment, Pkg Size 3 g Tube, Generic for: Maxitrol,…
- FDA Drug
- Class II
- terminated
- Published 2019-07-31
On 2019-07-31 the FDA classified a Class II recall of Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg Ophthalmic Ointment, Pkg Size 3 g Tube, Generic for: Maxitrol,… by Preferred Pharmaceuticals, citing CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1491-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-18 |
| Published | 2019-07-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Preferred Pharmaceuticals |
| Distribution | CA, FL |
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
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Identifiers
| code_info | Lot #: L2117Q, Batch: 12211717, Exp. 09/2019; F2818H, Batch: 06281808, Exp. 11/2019; B1819T, Batch: B1819T001 to B1819T048 (Inclusive), Exp. 05/2020. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1491-2019%22
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