Class I - Dangerous
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-766-16
Perrigo Company PLC
Class I - Dangerous
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class I - Dangerous
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class I - Dangerous
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Acetaminophen Oral Suspension Grape Flavor, 160 mg per 5 mL, 16 fl oz (473 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 50941-009-43
Perrigo Company PLC
Class I - Dangerous
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Nasal Spray Decongestant, No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10
Perrigo Company PLC
Class I - Dangerous
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
Children's Cherry Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 45802-203-26
Perrigo Company PLC
Class I - Dangerous
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Children's Pain & Fever Acetaminophen, 160 mg per 5 mL Oral Suspension combo pack. DS SR APAP 160MG CHLD BBGM/DF CHRY/GRP. UPC: 3 70030 11637 9
Perrigo Company PLC
Class I - Dangerous
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class I - Dangerous
cGMP deviations
365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL
Je Dois Lavoir
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.
Class I - Dangerous
cGMP Deviations
Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: Fontida Bio Pharm Inc., 1100 Orthodox St. Philadephia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-648-88.
SUN PHARMACEUTICAL INDUSTRIES
Class I - Dangerous
Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLDZLY2, UPC 742137 605191.
ABC Sales 1
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.
Class I - Dangerous
Non-sterility; bacterial contamination identified as Paenibacillus lautus.
Class I - Dangerous
cGMP Deviations
THE RED PILL, EXTRA STRENGTH capsules, 800 mg, packaged in 10-count blisters packaged in a carton, ASIN B0847BSQQ5, Barcode X002G5GMJ1.
Your Favorite Shop
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification results for related substances.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx- Joint Cream, 4 oz tubes, Manufactured for NaturesPlus 548 Broadhollow Road, Melville, NY 11747, USA
Organics Corporation of America
Class I - Dangerous
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter gergoviae.