Food, drugs, devices › Preferred Pharmaceuticals, Inc
Drug recall: Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg Ophthalmic Ointment, Pkg Size 3 g Tube, Gene
Preferred Pharmaceuticals, Inc (Anaheim, CA) initiated this drug recall on 18 Jul 2019; FDA lists 1 product record under event 83370, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 68% of the 362 drug enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 24 Apr 2023. Initiation: voluntary: firm initiated. Preferred Pharmaceuticals, Inc has 32 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Preferred Pharmaceuticals, Inc, Anaheim, CA.
Reason for recall
"CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility."
Distribution
"CA, FL"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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, For External Use Only, Rx only, Mfg: Paddock Laboratories, LLC, Preferred Pharmaceuticals, Inc., The Physicians Solutions, Anaheim, CA, NDC 68788-9373-03. | 171 tubes | Class II | Terminated | 31 Jul 2019 |
Context
Other enforcement events for Preferred Pharmaceuticals, Inc
All 32 events for Preferred Pharmaceuticals, Inc
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "CA, FL"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 24 Apr 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.