Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10 recall: CGMP Deviations
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…
Why was Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10 recalled?
CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: L2117Q, Batch: 12211717, Exp. 09/2019; F2818H, Batch: 06281808, Exp. 11/2019; B1819T, Batch: B1819T001 to B1819T048 (Inclusive), Exp. 05/2020.
- 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…
- Recalling firm
- Preferred Pharmaceuticals, Inc
- Quantity
- 171 tubes
- Distribution
- CA, FL
- Recall date
- July 31, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)