Class I - Dangerous
Failed impurities/degradation specifications
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Labeling - product contains undeclared ethyl alcohol
Class I - Dangerous
cGMP deviations
All Over-The-Counter (OTC) drug products sold by Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee.
Dollar Tree Distribution
Class I - Dangerous
CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center.
Class I - Dangerous
Labeling - product contains undeclared ethyl alcohol
Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-466-08.
Morton Grove Pharmaceuticals
Class I - Dangerous
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA. NDC 41163-703-10
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: 11673-105-26
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
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
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.
Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716. NDC: 49035-946-16
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 Perrigo, Allegan, MI 49010. NDC: 0113-8959-26
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 Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC: 0363-0971-26
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.
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.