Drug product
Metformin Hydrochloride Tablets USP 500 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134 NDC 24658-290-05
D-1301-2014
Product summary
- Event
- Event 67739
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,000 tablets
- Official record key
drug-enforcement:D-1301-2014
Official wording
Reason: Defective container: Product distributed without inner seal on bottles.
Code information: Lot # 13E0008F3P8V; Exp. 03/15
Distribution pattern: NJ, UT, IL and CT
Derived failure modes
-
Unknown
Defective container: Product distributed without inner seal on bottles.