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.
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.
Lot numbers, UPCs & expiration codes
CK2003, CK2004 exp. 04/15, CR4110, CR4111, CS2983, CS2986, CS2988, CS2989, CS2990, CS2991, CS2992, CS2993, CS2994 exp. 07/15, CK3616, CK3617 exp. 04/15
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-268-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 18, 2013
- FDA report date
- May 1, 2013
- Quantity
- 8286 x 30 ct, 37108 x 500 ct. bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Incorporated
Original FDA data
Every field from FDA enforcement report D-268-2013, exactly as published.
Show all FDA fields
- City
- Broomfield
- State
- CO
- Status
- Terminated
- Country
- United States
- Event ID
- 64936
- Address
- 2555 W Midway Blvd
- 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
- Postal code
- 80020-1632
- Report date
- May 1, 2013
- Product type
- Drugs
- Recall number
- D-268-2013
- Classification
- Class II
- Recalling firm
- Sandoz Incorporated
- Product quantity
- 8286 x 30 ct, 37108 x 500 ct. bottles
- Termination date
- Feb 26, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 18, 2013
- Initial firm notification
- Letter
- Center classification date
- Apr 23, 2013