Class I - Dangerous
Product mixup: one foreign tablet found in product.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
Class I - Dangerous
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count Caplets
Family Dollar Stores
Class I - Dangerous
CGMP deviation: product outside labeled storage temperature requirements.
Glimepiride USP, 4 mg, 90 count-bottles, Rx only, Intas Pharm. Limited Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0587-90
PD-Rx Pharmaceuticals
Class I - Dangerous
CGMP deviations.
Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles
Family Dollar Stores
Class I - Dangerous
CGMP deviation: product outside labeled storage temperature requirements.
Montelukast Sodium USP, 10 mg, 30 count-bottles, Rx only, Intas Pharm, Limited Ahmedabad 380 054 India Pkg By: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127, NDC 43063-0762-30
PD-Rx Pharmaceuticals
Class I - Dangerous
CGMP deviations.
Class I - Dangerous
CGMP deviations.
DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC 6 75799 37602 7.
Gadget Island
Class I - Dangerous
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I - Dangerous
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I - Dangerous
Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.
Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c) 3 (2 count) packets.
Family Dollar Stores
Class I - Dangerous
CGMP deviation: product outside labeled storage temperature requirements.
NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power CO., Chicago, Il 60612, UPC 6 01577 51236 3.
Gadget Island
Class I - Dangerous
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I - Dangerous
CGMP deviations.
Class I - Dangerous
CGMP deviations.
Class I - Dangerous
Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
Advil Liqui-Gels Solubilized Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) a) 20-count Liquid Filled Capsule bottles; b) 40-count Liquid Filled Capsule bottles.
Family Dollar Stores
Class I - Dangerous
CGMP deviation: product outside labeled storage temperature requirements.
Class I - Dangerous
CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
Northwind Pharmaceuticals
Class I - Dangerous
CGMP Deviations
BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-511-52
Northwind Pharmaceuticals
Class I - Dangerous
CGMP Deviations