Drug product
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.
D-0511-2026
Product summary
- Event
- Event 98728
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 10,875 Bottles
- Official record key
drug-enforcement:D-0511-2026
Official wording
Reason: Subpotent drug
Code information: Lot: ZBUL25001, Exp 12/31/2027
Distribution pattern: USA Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent