Sandoz Recalls Amoxicillin Capsules Due to Stainless Steel Contamination
Sandoz is recalling specific lots of Amoxicillin Capsules USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a physical foreign substance (stainless steel wire mesh) in an oral medication, which poses a risk of injury (such as choking or internal damage) even though no specific injuries are reported in the source text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sandoz Incorporated is recalling certain lots of Amoxicillin Capsules, USP 500 mg. The recall is being conducted because the product may be contaminated with fragments of stainless steel wire mesh.
The affected product is Amoxicillin Capsules USP 500 mg, manufactured in Austria by Sandoz GmbH for Sandoz Inc. The recall includes 30-count and 500-count bottles (NDC 0781-2613-31 and NDC 0781-2613-05). The specific lot codes involved are CK2003, CK2004, CR4110, CR4111, CS2983, CS2986, CS2988, CS2989, CS2990, CS2991, CS2992, CS2993, CS2994, CK3616, and CK3617.
Consumers should check their medication for these specific lot codes and expiration dates (04/15 or 07/15). If the product matches the recalled lots, consumers should stop using it and contact their healthcare provider or pharmacist for guidance on replacement or disposal.
The recalled product
- Product
- AMOXICILLIN (AMOXICILLIN)
- Brand
- AMOXICILLIN
- Manufacturer
- Sandoz Incorporated
- Category
- Drug — Antibiotic
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- CK2003
- CK2004 exp. 04/15
- CR4110
- CR4111
- CS2983
- CS2986
- CS2988
- CS2989
- CS2990
- CS2991
- CS2992
- CS2993
- CS2994 exp. 07/15
- CK3616
- CK3617 exp. 04/15
UPCs (8)
- 0307816156526
- 0307812020012
- 0307816041587
- 0307815060015
- 0307815061012
- 0307816157523
- 0307816039584
- 0307812613016
Distribution
Distributed nationwide across the United States.
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