Class I - Dangerous
CGMP Deviations
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Other Drugs
💊 Drugs • 3,313 recalls
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Microbial Contamination of Non-Sterile Product
Class I - Dangerous
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
The Natural Dentist Healthy Balance Peppermint Sage, Menthol 0.12%, 16.9 FL OZ (500 mL) bottles, Manufactured for Revive Personal Products Company, Madison, NJ 07940, UPC 7 14132 00071 4
Revive Personal Products Company
Class I - Dangerous
Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8
Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in 55-gallon drums, Aroma Release Technology, Inc., 7026 Discovery Drive, Chattanooga, TN 37416
Aroma Release Technologies
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166 UPC 0 00856 00309 5, NDC 58593-828-08
Efficient Laboratories
Class I - Dangerous
Microbial Contamination of Non-Sterile Products
Class I - Dangerous
Defective Container: Customer complaints for leaking bottles and dispensing issues.
Rompe Pecho Ex Expectorant, packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58593-829-04 and b) 6 Fl. Oz. (178 mL) bottles NDC 58593-829-06, Distributed by Efficient Laboratories, Inc. Miami, FL 33166
Efficient Laboratories
Class I - Dangerous
Microbial Contamination of Non-Sterile Products
Rompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-275-06
Efficient Laboratories
Class I - Dangerous
Microbial Contamination of Non-Sterile Products
Class I - Dangerous
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418; (b)Product of Finland 20006106; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 3 11017 41009 7, NDC 11523-0777-2.
Bayer Healthcare Pharmaceuticals
Class I - Dangerous
Chemical Contamination: presence of benzene
Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41005 9, NDC 11523-0165-3.
Bayer Healthcare Pharmaceuticals
Class I - Dangerous
Chemical Contamination: presence of benzene
Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, labeled as (a) UPC 3 11017-410-00 4, NDC 11523-4162-1, Product of Finland 86568411; (b) UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981
Bayer Healthcare Pharmaceuticals
Class I - Dangerous
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8
Bayer Healthcare Pharmaceuticals
Class I - Dangerous
Chemical Contamination: presence of benzene
LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3
Bayer Healthcare Pharmaceuticals
Class I - Dangerous
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 58720 6, NDC 11523-0010-2.
Bayer Healthcare Pharmaceuticals
Class I - Dangerous
Chemical Contamination: presence of benzene
LOTRIMIN AF (Tolnaftate 1%) DAILY PREVENTION deodorant powder spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 59036 7, NDC 11523-0010-1.
Bayer Healthcare Pharmaceuticals
Class I - Dangerous
cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.
LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3
Bayer Healthcare Pharmaceuticals
Class I - Dangerous
Chemical Contamination: presence of benzene