Recall archive
29 recalls · page 2 of 2
Reported Jul 31, 2019
Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg Ophthalmic Ointment, Pkg Size 3 g Tube,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Preferred Pharmaceuticals, Inc.
Matched: Brand · Product details — CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufacturing facility.
FDA (openFDA drug enforcement)
Reported Jun 26, 2019
Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr, USP 10mg,/Guaifenesin, USP…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Preferred Pharmaceuticals, Inc.
Matched: Brand · Product details — CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
FDA (openFDA drug enforcement)
Reported May 22, 2019
Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Preferred Pharmaceuticals, Inc.
Matched: Brand · Product details — CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
FDA (openFDA drug enforcement)
Reported Mar 27, 2019
Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Preferred Pharmaceuticals, Inc.
Matched: Brand · Product details — CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
FDA (openFDA drug enforcement)
Reported Aug 29, 2018
Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Preferred Pharmaceuticals, Inc.
Matched: Brand · Product · Product details — CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
FDA (openFDA drug enforcement)
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