Class II · Moderate risk
Amoxicillin and Clavulanate Potassium for Oral Suspension USP
Subpotent drug; Clavulanate Potassium component
Amoxicillin Capsules USP 500 mg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What 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.
Affected NDCs
0781-2613-05
0781-2613-31
Compare with the code on your package — it is the most precise check available.
Drug: Amoxicillin Category: Antibiotic
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Amoxicillin NDC 00781-2613 |
500 mg/1 | Capsule Oral |
Sandoz Inc | Rx |
- Recalling firm
- Sandoz Incorporated
- NDC code
- 0781-2613-05
- Origin
- CO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-268-2013 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Amoxicillin recalls
See all
Class II · Moderate risk
Amoxicillin and Clavulanate Potassium Tablets USP
Subpotent Drug
Class II · Moderate risk
Amoxicillin Capsules
cGMP deviations: Temperature abuse
Class II · Moderate risk
AMOXICILLIN Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
AMOXICILLIN for Oral Suspension USP
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Other recalls by Sandoz Incorporated
All 2013 recalls
Class III · Low risk
Triamterene and Hydrochlorothiazide Tablets
Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
Class III · Low risk
Amitriptyline HCl Tablets
Cross Contamination With Other Product: Imipramine
Class II · Moderate risk
Nadolol Tablets
Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
Class III · Low risk
Fluoxetine Capsules USP
Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.
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