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U.S. Department of Health and Human Services

Enforcement Report - Week of May 1, 2013

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Product Detail

Product Description Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only. Manufactured in 500 ct (NDC 0781-2613-05) and 30 ct (NDC 0781-2613-31) bottles.
Recall Number D-268-2013
Classification Class II
Code Info CK2003, CK2004 exp. 04/15, CR4110, CR4111, CS2983, CS2986, CS2988, CS2989, CS2990, CS2991, CS2992, CS2993, CS2994 exp. 07/15, CK3616, CK3617 exp. 04/15
Product Distributed Qty 8286 x 30 ct, 37108 x 500 ct. bottles
Reason For Recall Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.

Event Detail

Event Id 64936
Product Type Drugs
Status Ongoing
Recalling Firm Sandoz Incorporated
City Broomfield
State CO
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-18
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide