Recalls / Class II
Class IID-268-2013
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.
- Brand name
- Amoxicillin
- Generic name
- Amoxicillin
- Active ingredient
- Amoxicillin
- Route
- Oral
- NDCs
- 0781-2020, 0781-2613, 0781-5060, 0781-5061, 0781-6039, 0781-6156, 0781-6041, 0781-6157
- FDA application
- ANDA064076
- Affected lot / code info
- CK2003, CK2004 exp. 04/15, CR4110, CR4111, CS2983, CS2986, CS2988, CS2989, CS2990, CS2991, CS2992, CS2993, CS2994 exp. 07/15, CK3616, CK3617 exp. 04/15
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.
Recalling firm
- Firm
- Sandoz Incorporated
- Manufacturer
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2555 W Midway Blvd, Broomfield, Colorado 80020-1632
Distribution
- Quantity
- 8286 x 30 ct, 37108 x 500 ct. bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-04-18
- FDA classified
- 2013-04-23
- Posted by FDA
- 2013-05-01
- Terminated
- 2014-02-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-268-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.