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.
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