Class I - Dangerous
Subpotent Drug.
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Prescription Drugs
💊 Drugs • 11,927 recalls
Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-788-20
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Class I - Dangerous
Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.
Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045. NDC 68645-578-54
Legacy Pharmaceutical Packaging
Class I - Dangerous
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Class I - Dangerous
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 --- NDC 52343-123-90
Rising Pharmaceuticals
Class I - Dangerous
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Class I - Dangerous
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-573-90
Aurobindo Pharma USA
Class I - Dangerous
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class I - Dangerous
Lack of Assurance of Sterility
Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90
Aurobindo Pharma USA
Class I - Dangerous
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Valsartan Tablets 160 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 ---- NDC 52343-124-90
Rising Pharmaceuticals
Class I - Dangerous
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Class I - Dangerous
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Class I - Dangerous
Microbial contamination
Class I - Dangerous
Microbial contamination
Class I - Dangerous
Microbial contamination
Class I - Dangerous
Microbial contamination
Class I - Dangerous
Microbial contamination
Class I - Dangerous
Microbial contamination
Class I - Dangerous
Microbial contamination
Class I - Dangerous
Microbial contamination
Class I - Dangerous
Microbial contamination