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Browse drug and medication recalls including prescription drugs, OTC medications, and supplements. Stay informed about pharmaceutical safety alerts.
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
This recall involves Scalpa Numb Maxium Strength Topical Anesthestic Cream in a 10 gram black and white tube with a white cap. "SCALPANUMB" and "Maximum Strength Topical Anesthetic Cream" are printed on the label. The expiration date is marked as EXP 202307 on the crimped end of the tube. Batch number 1000000101, Code: C1 and the UPC code 857076008689 are printed on the outside of the box.
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
This recall involves 50, 80, 100, 125, 200, 250 and 300-count bottles of Excedrin Migraine Caplets, Excedrin Migraine Geltabs, Excedrin Extra Strength Caplets, Excedrin PM Headache Caplets, and Excedrin Tension Headache Caplets. The bottles are plastic with a child-resistant closure. For a full list of the recalled products, visit www.excedrin.com/products/discontinued.
The firm is recalling their products due the unapproved use of a food additive and unapproved marketing statements
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
This recall involves The Vitamin Shoppe's Vthrive Bioactive Women's One-Daily Multi vitamins. The 60-count capsules were sold in an amber bottle with a gray top. Vthrive and Bioactive Women's One-Daily Multi are printed on a blue label on the bottle. Item number VS-6104 can be found on the back of the bottle and lot number 006218, 006454, 006495 or 006779 on the bottle's underside. Only the 60-count bottles are included in this recall.
The recall involves 31 different over-the-counter drugs purchased on or after June 1, 2018 that are unexpired from the following brands: Medi-First, Medi-First Plus, Medique, Dover, Otis Clapp, and Ecolab. They include aspirin-containing products, acetaminophen-containing products, ibuprofen-containing products, lidocaine-containing products, diphenhydramine, loperamide, and naproxen products. The expiration date for tablets and creams can be found on either the top or side panels of the container carton in the format [YEAR/MO]. For products in spray bottles, the expiration date in the same format is located on the front of the bottle. The expiration date is found on the bottom for the spray cans. The 31 different recalled products are listed in the table below: Product Drug Package Type # of Packets Medi-First Non-Aspirin Acetaminophen acetaminophen (325 mg) 2 tablets packet 50 250 Medi-First Extra Strength Non-Aspirin Acetaminophen acetaminophen (500 mg) 2 tablets packet 50 125 250 Medi-First Sinus Pain & Pressure acetaminophen (500 mg) 2 tablets packet 50 125 250 Medique APAP acetaminophen (325 mg) 2 tablets packet 250 Medique Extra Strength APAP acetaminophen (500 mg) 2 tablets packet 50 125 250 Medique Back Pain-Off acetaminophen (250 mg) 2 tablets packet 50 100 250 Medique CCP Caffeine Fee acetaminophen (325 mg) 2 tablets packet 50 250 Medi-First Cold Relief acetaminophen (325 mg) 2 tablets packet 50 125 250 Medique Cramp Tabs acetaminophen (325 mg) 2 tablets packet 50 125 250 Medique Decorel Forte Plus acetaminophen (325 mg) 2 tablets packet 50 250 Medique Medicidin-D acetaminophen (325 mg) 2 tablets packet 50 100 250 Dover Aminofen acetaminophen (325 mg) 2 tablets packet 250 Otis Clapp Back Quell acetaminophen (200 mg) 2 tablets packet 150 Otis Clapp Mygrex acetaminophen (500 mg) 2 tablets packet 150 Otis Clapp Valihist acetaminophen (325 mg) 2 tablets packet 150 Medi-First Pain Relief Extra Strength acetaminophen (110 mg) aspirin (162 mg) 2 tablets packet 50 100 250 Medi-First Plus Pain Zappers acetaminophen (250 mg) aspirin (250 mg) 2 tablets packet 50 125 Medique Pain-Off acetaminophen (250 mg) aspirin (250 mg) 2 tablets packet 50 100 250 Medi-First Aspirin aspirin (325 mg) 2 tablets packet 50 125 250 Medi-First Plus Aspirin aspirin (325 mg) 2 tablets packet 50 125 Medique Aspirin aspirin (325 mg) 2 tablets packet 12 100 250 Medique Diphen diphenhydramine (25 mg) 1 tablet packet 24 200 Medi-First Ibuprofen ibuprofen (200 mg) 2 tablets packet 4 50 125 250 Medique I-Prin ibuprofen (200 mg) 2 tablets packet 3 100 250 Dover Addaprin ibuprofen (200 mg) 2 tablets packet 250 Medi-First Burn Cream with Lidocaine lidocaine (0.9 grams) packets 25 Medi-First Burn Spray lidocaine HCl (2%) 2 oz bottle -- Medi-First Blood Clotting Spray lidocaine (4%) 3 oz bottle -- Ecolab Burn Cream lidocaine (0.9 grams) packets 25 Medique Diamode loperamide HCl (2 mg) 1 tablet packet 6 50 100 Medique Mediproxen naproxen sodium (220 mg) 1 tablet packet 50 100
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level