Recalls / Class II
Class IID-0067-2019
Product
Rite Aid Pharmacy, First Aid Antibiotic Ointment, (neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units, bacitracin zinc 400 units per gram), 2 OZ (56 g) tube, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 55441 1.
- Affected lot / code info
- Lot: 170591E, Exp. 11/17/18
Why it was recalled
Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
Recalling firm
- Firm
- Product Quest Manufacturing LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 330 Carswell Ave, N/A, Daytona Beach, Florida 32117-4416
Distribution
- Quantity
- 5,004 tubes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-08-03
- FDA classified
- 2018-10-16
- Posted by FDA
- 2018-10-24
- Terminated
- 2021-03-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0067-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.