D-1301-2014 Class II Terminated
FDA drug recall D-1301-2014 was initiated by Blu Pharmaceuticals Inc on March 13, 2014 and is designated Class II. Reason for recall: Defective container: Product distributed without inner seal on bottles. The recall status is terminated (terminated June 10, 2015). Affected quantity: 14,000 tablets.
Recall Details
- Product Type
- Drugs
- Report Date
- May 14, 2014
- Initiation Date
- March 13, 2014
- Termination Date
- June 10, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,000 tablets
Product Description
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
Reason for Recall
Defective container: Product distributed without inner seal on bottles.
Distribution Pattern
NJ, UT, IL and CT
Code Information
Lot # 13E0008F3P8V; Exp. 03/15