Drug product
CVS Health, Original Strength, Triple Antibiotic Ointment Spray (bacitracin zinc 400 units, neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units per gram), 2 OZ (57 g) can, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Product#957603, UPC 0 50428 29525 0.
D-0073-2019
Product summary
- Event
- Event 80750
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,016 cans
- Official record key
drug-enforcement:D-0073-2019
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