Drug product
Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24
D-0029-2025
Product summary
- Event
- Event 95590
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,901 cases/24 count each case
- Official record key
drug-enforcement:D-0029-2025
Official wording
Reason: Superpotent Drug: Stability failure for assay at 6 months test time-point.
Code information: Lot # 24A27724, Exp 01/31/2027
Distribution pattern: Product was shipped to two private label customers ( OH & MO) as a final packaged product.
Derived failure modes
-
Potency or specification failure
Superpotent