Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-162-02
Fresenius Kabi USA
Class I - Dangerous
Presence of Particulate Matter - found in reserve sample vials at the firm.
Happy Ducts Compress, 3 oz. plastic jar, www.wishgardenherbs.com, Boulder, CO. 80301. UPC 6 56490 20223 5
Wishgarden Herbs, Incorporated
Class I - Dangerous
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Class I - Dangerous
Failed Impurity/Degradation Specifications
Class I - Dangerous
Failed Moisture Limits
Class I - Dangerous
Failed Impurity/Degradation Specifications
Goldenseal POWDER, 0.25 oz. (7 g) plastic jars, WishGarden Herbs, Inc., Boulder, CO 80301. UPC 6 56490 64137 9
Wishgarden Herbs, Incorporated
Class I - Dangerous
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Cord Care POWDER, 0.25 oz. (7 g) plastic jars, Wishgarden Herbs, Inc., Boulder, CO 80301. UPC 6-56490 24730 4
Wishgarden Herbs, Incorporated
Class I - Dangerous
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Class I - Dangerous
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Class I - Dangerous
CGMP Deviations
Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only, Single Dose Container, SCA Pharmaceuticals 8821 Knoedl Ct. Little Rock, AR 72205 Bar Code 70004093232
SCA Pharmaceuticals
Class I - Dangerous
Subpotent drug.
Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053
Morton Grove Pharmaceuticals
Class I - Dangerous
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Kroger Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 0.5 OZ (15g), Distributed by The Kroger Co. Cincinnati, Ohio 45202 Made in Canada. NDC 30142-305-01
Taro Pharmaceuticals U.S.A.
Class I - Dangerous
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
BPC-157, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Advanced Nutriceuticals
Class I - Dangerous
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class I - Dangerous
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Advanced Nutriceuticals
Class I - Dangerous
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
TopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT. 0.5 oz. (14.2 g). Distributed by Topco Associates LLC, Elk Grove Village, IL 60007. NDC 36800-495-69 UPC 0 36800 49569 2
Taro Pharmaceuticals U.S.A.
Class I - Dangerous
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Advanced Nutriceuticals
Class I - Dangerous
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Advanced Nutriceuticals
Class I - Dangerous
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.