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
17,685 Total Recalls
Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle Brook, NJ 07863, NDC 64980-221-01
RISING PHARMACEUTICALS
Class I - Dangerous
Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.
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, MADE WITH PRIDE & CARE FOR H-E-B SAN ANTONIO, TX 78204. NDC: 37808-759-26
Perrigo Company PLC
Class I - Dangerous
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, DISTRIBUTED BY FOODHOLD U.S.A., LLC, LANDOVER, MD 20785. NDC 41520-108-10
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.
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007. NDC 36800-388-10
Perrigo Company PLC
Class I - Dangerous
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 0113-0020-26
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.
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.
Acetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Distributed by Target Corporation, Minneapolis, MN 55403. NDC: 11673-133-16
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.
No Drip Nasal Decongestant, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: BETTER LIVING BRANDS LLC, P.O. BOX 99, PLEASANTON, CA 94566-0009. NDC 21130-801-10
Perrigo Company PLC
Class I - Dangerous
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class I - Dangerous
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-305-62
Dr. Reddy's Laboratories
Class I - Dangerous
Failed stability specifications
Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716. NDC: 49035-959-26
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.
Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-465-62
Dr. Reddy's Laboratories
Class I - Dangerous
Failed stability specifications
Class I - Dangerous
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.