Drug recall D-268-2013

Class II Terminated reported May 1, 2013

Product

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.

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.

Lots and codes

CK2003, CK2004 exp. 04/15, CR4110, CR4111, CS2983, CS2986, CS2988, CS2989, CS2990, CS2991, CS2992, CS2993, CS2994 exp. 07/15, CK3616, CK3617 exp. 04/15

Recall details

Recalling firm
Sandoz Incorporated, Broomfield, CO
Quantity
8286 x 30 ct, 37108 x 500 ct. bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
April 18, 2013
Terminated
February 26, 2014

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