Drug 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.
D-0067-2019
Product summary
- Event
- Event 80750
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,004 tubes
- Official record key
drug-enforcement:D-0067-2019
Official wording
Reason: Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
Code information: Lot: 170591E, Exp. 11/17/18
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent