Class I - Dangerous
Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Class I - Dangerous
Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.
Class I - Dangerous
Failed Dissolution Specifications; 36 month stability timepoint
SLIMDIA Revolution capsules, 30-count capsules per bottle, Yerba Naturals, 19685 Varda Ave., Buena Park, CA.
P & J Trading
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: All lots of the dietary supplement Slimdia Revolution are being recalled because they contain sibutramine, a previously approved FDA drug removed from the U.S. marketplace for safety reasons, making it an unapproved new drug.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 cards each containing 20 blistered tablets per carton, Rx only; Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, Pkg by & Distributed by UDL Laboratories, Inc., Rockford, IL 61103; NDC 51079-254-21.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Class I - Dangerous
Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Crest PRO-HEALTH CPC Antigingivitis/Antiplaque Oral Rinse, 250 mL (8.4 fl oz),Dist. by Procter & Gamble, Cincinnati, OH 45202 NDC 37000-452-02
Procter & Gamble Hair Care
Class I - Dangerous
Cross Contamination with Other Products: Product was mixed with another type of mouth wash.
Class I - Dangerous
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ, 07724, NDC 0143-1250-01.
West-ward Pharmaceutical
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, Rx only, Manufactured for Upsher Smith Laboratories, Inc Minneapolis MN 55447 --- NDC 0245-0085-11, UPC 3 0245-0085-11 9
Upsher Smith Laboratories
Class I - Dangerous
Failed Dissolution Test Requirements
Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeling are being recalled due to microbial contamination identified during testing.
Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection.
Class I - Dangerous
Defective Container: Pump head detaching from the canister unit upon removal of the overcap.
Class I - Dangerous
Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.
Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per carton, Manufactured for Actelion Pharmaceuticals US, Inc, 5000 Shoreline Court, Ste 200, South San Francisco, CA 94080, NDC: 66215-302-30.
Actelion Pharmaceuticals U.S.
Class I - Dangerous
Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.
Class I - Dangerous
Failed Dissolution Specification: Out of a specification result occurred during the 3-month stability testing. Dissolution result at the 4-hour time point was 41% (specification: 20-40%).
Class I - Dangerous
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Class I - Dangerous
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
Class I - Dangerous
Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia.