PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: May 1, 2013 Initiated: April 18, 2013 #D-268-2013

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.

Details

Recalling Firm
Sandoz Incorporated
Units Affected
8286 x 30 ct, 37108 x 500 ct. bottles
Distribution
Nationwide
Location
Broomfield, CO

Frequently Asked Questions

What product was recalled?
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.. Recalled by Sandoz Incorporated. Units affected: 8286 x 30 ct, 37108 x 500 ct. bottles.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 1, 2013. Severity: Moderate. Recall number: D-268-2013.