Class I — High risk. Reasonable probability of serious harm or death.
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100 Tablets per Bottle, NDC: 65162-271-10, b) 500 Tablets per Bottle, NDC: 65162-271-50, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.
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 65162-0271 |
SULFAMETHOXAZOLE 400 mg/1; TRIMETHOPRIM 80 mg/1 | Tablet Oral |
Amneal Pharmaceuticals LLC | Rx |
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
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 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.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
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.
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