Why it was recalled
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: L2117Q, Batch: 12211717, Exp. 09/2019; F2818H, Batch: 06281808, Exp. 11/2019; B1819T, Batch: B1819T001 to B1819T048 (Inclusive), Exp. 05/2020.
Where it was sold
CA, FL
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1491-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 18, 2019
- FDA report date
- Jul 31, 2019
- Quantity
- 171 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Preferred Pharmaceuticals, Inc
Original FDA data
Every field from FDA enforcement report D-1491-2019, exactly as published.
Show all FDA fields
- City
- Anaheim
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 83370
- Address
- 1250 N Lakeview Ave Ste O
- Code information
- Lot #: L2117Q, Batch: 12211717, Exp. 09/2019; F2818H, Batch: 06281808, Exp. 11/2019; B1819T, Batch: B1819T001 to B1819T048 (Inclusive), Exp. 05/2020.
- Postal code
- 92807-1801
- Report date
- Jul 31, 2019
- Product type
- Drugs
- Recall number
- D-1491-2019
- Classification
- Class II
- Recalling firm
- Preferred Pharmaceuticals, Inc
- Product quantity
- 171 tubes
- Termination date
- Apr 24, 2023
- Reason for recall
- CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- CA, FL
- Recall initiation date
- Jul 18, 2019
- Initial firm notification
- Center classification date
- Jul 22, 2019