D-268-2013 Class II Terminated
FDA drug recall D-268-2013 was initiated by Sandoz Incorporated on April 18, 2013 and is designated Class II. 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. The recall status is terminated (terminated February 26, 2014). Affected quantity: 8286 x 30 ct, 37108 x 500 ct. bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 1, 2013
- Initiation Date
- April 18, 2013
- Termination Date
- February 26, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8286 x 30 ct, 37108 x 500 ct. bottles
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.
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.
Distribution Pattern
Nationwide
Code Information
CK2003, CK2004 exp. 04/15, CR4110, CR4111, CS2983, CS2986, CS2988, CS2989, CS2990, CS2991, CS2992, CS2993, CS2994 exp. 07/15, CK3616, CK3617 exp. 04/15