Reported May 1, 2013 · Terminated
Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only.…
Sandoz Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sandoz Incorporated · 2555 W Midway Blvd · Broomfield, CO · 80020-1632
Is this the product you have?
- 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.
- Lot codes and dates
CK2003CK2004 exp. 04/15CR4110CR4111CS2983CS2986CS2988CS2989CS2990CS2991CS2992CS2993CS2994 exp. 07/15CK3616CK3617 exp. 04/15
- Amount recalled
- 8286 x 30 ct, 37108 x 500 ct. bottles
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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