Class I - Dangerous
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684
Promise Pharmacy
Class I - Dangerous
Presence of precipitate
Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11
Upsher Smith Laboratories
Class I - Dangerous
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875519155
Valeant Pharmaceuticals North America
Class I - Dangerous
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Class I - Dangerous
Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Thayers Natural Remedies, Saline Nasal Spray, Allergy & Sinus Relief, Slippery Elm, 1.5 FL OZ (44 mL) bottle, Distributed By: Product Quest Manufacturing, LLC, 330 Carswell Ave., Daytona Beach, FL 32117, UPC 7 27510 00660 4.
Product Quest Manufacturing
Class I - Dangerous
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class I - Dangerous
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class I - Dangerous
CGMP Deviations: products manufactured under conditions that could impact its product quality.
QC Quality Choice, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14.1 g) tube, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, UPC 6 35515 99202 3.
Product Quest Manufacturing
Class I - Dangerous
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Best Choice, 12 Hour Extra Moisturizing, Nasal Spray (Oxymetazoline Hydrochloride 0.05%), Nasal Decongestant, 1 FL OZ (30 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave., Kansas City, KS 66106, UPC 0 70038 59328 7.
Product Quest Manufacturing
Class I - Dangerous
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Well at Walgreens, Scar Cream with SPF 30, (Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%), 0.7 OZ (19.8 g) tube, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, UPC 3 11917 18281 0.
Product Quest Manufacturing
Class I - Dangerous
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48 pk. (12687901)
Product Quest Manufacturing
Class I - Dangerous
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Finafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube, Distributed By: Efficient Laboratories, Inc., Miami, FL 33166.
Product Quest Manufacturing
Class I - Dangerous
CGMP Deviations: products manufactured under conditions that could impact its product quality.
TopCare, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14 g) tube, Distributed By Topco Associates LLC, Elk Grove Village, IL 60007, UPC 0 36800 42146 2.
Product Quest Manufacturing
Class I - Dangerous
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class I - Dangerous
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Family Dollar Saline Nasal Spray 4.25 oz. can, 24 pk, SKU 0900562.
Product Quest Manufacturing
Class I - Dangerous
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Cicatricure, Scar Cream + Sunscreen SPF 30 (avobenzone 3%, octocrylene 10%, oxybenzone 6%), 0.7 oz. (19.8 g) tube, Distributed by: Genomma Lab USA Inc., Houston, TX 77027, UPC 6 50067 00018 7.
Product Quest Manufacturing
Class I - Dangerous
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Sinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 43236 5.
Product Quest Manufacturing
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.
Class I - Dangerous
Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
Mushatt's No. 9, PsoriWash Medicated Wash, Salicylic Acid 1.8%, 8 oz. (226 g) tube, Distributed by Mushatts, LLC, P.O. Box 372476, Satellite Beach, FL 32937, UPC 8 58245 00203 3.
Product Quest Manufacturing
Class I - Dangerous
Microbial Contamination of Non-Sterile Products and Subpotent Drug: failure for microbiological growth exceeding specification and low out of specification assay results for salicylic acid.