Class I - Dangerous
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
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.
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.
Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by: Walmart, Inc., Bentonville, AR 72716. NDC: 49035-042-26
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.
Class I - Dangerous
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
Class I - Dangerous
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
Positive Health
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
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716. NDC 49035-388-10
Perrigo Company PLC
Class I - Dangerous
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentoneville, AR 72716. NDC: 49035-766-16
Perrigo Company PLC
Class I - Dangerous
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Target Corporation, Minneapolis, MN 55403. NDC: 11673-759-26
Perrigo Company PLC
Class I - Dangerous
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202. NDC: 30142-818-26
Perrigo Company PLC
Class I - Dangerous
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by Target Corp., Minneapolis, MN 55403 NDC: 11673-130-26
Perrigo Company PLC
Class I - Dangerous
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-865-60
Dr. Reddy's Laboratories
Class I - Dangerous
Failed stability specifications