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U.S. Department of Health and Human Services

Enforcement Report - Week of May 14, 2014

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Product Detail

Product Description Metformin Hydrochloride Tablets USP 1000 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134, NDC 24658-0292-05
Recall Number D-1302-2014
Classification Class II
Code Info Lot # 13E0014F1P8V; Exp. 04/15
Product Distributed Qty 101,500 tablets
Reason For Recall Defective container: Product distributed without inner seal on bottles.

Event Detail

Event Id 67739
Product Type Drugs
Status Ongoing
Recalling Firm Blu Pharmaceuticals Inc
City Franklin
State KY
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-03-13
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern NJ, UT, IL and CT