CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Drugs Recalls
Prescription and over-the-counter medications
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
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
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
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
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.
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
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
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
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
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
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
Failed stability specifications
Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%, packaged in IV bags, Rx only, BayCare Central Pharmacy 7802 E. Telecom Parkway Temple Terrace, FL 33637 (813) 901-6392
BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy
Subpotent drug
Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), two 4 FL OZ (118 mL) bottles per pack, Distributed by Walmart Inc., Bentonville, AR 72716. NDC: 49035-313-26
Perrigo Company PLC
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Dist. by Target Corp., Mpls., MN 55403. NDC 11673-935-10
Perrigo Company PLC
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.