Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
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.
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count bottles (NDC 51655-307-53), c) 14-count bottles (NDC 51655-307-84), d) 20-count bottles (NDC 51655-307-20) Rx Only, Repackaged from Amneal Pharmaceuticals LLC. Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46203.
Compare with the code on your package — it is the most precise check available.
Drug: Trimethoprim
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 |
|---|---|---|---|---|
| Sulfamethoxazole and Trimethoprim NDC 51655-0307 |
SULFAMETHOXAZOLE 800 mg/1; TRIMETHOPRIM 160 mg/1 | Tablet Oral |
Northwind Health Company, LLC | Rx |
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.
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
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