Drug product
Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC. East Brunswick, NJ 08816. NDC# 29300-137-01
D-1541-2022
Product summary
- Event
- Event 90709
- Status
- Terminated
- Classification
- Class III
- Quantity
- 18,960 bottles of 100
- Official record key
drug-enforcement:D-1541-2022
Official wording
Reason: Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
Code information: Lot # GCLH22005, exp. date 02/29/2024
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Unknown
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,