Drug and pharmaceutical recalls
17728 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIFamily Dollar Saline Nasal Spray 4.25 oz. can, 24 pk, SKU 0900562.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIFinafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube, Distributed By: Efficient Laboratories, Inc., Miami, FL 33166.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIRexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48 pk. (12687901)
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIRexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48/3/1 #12687901 w/ Silo
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIRexall, Sinus Nasal Pump Mist, (Oxymetazoline Hydrochloride 0.05%), 1 FL OZ (30mL) bottle, SKU 00744201
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIRhinall Nasal Decongestant Nasal Spray (phenylephrine HCl), 0.25%, 1 1/3 Fl Oz. (40 ml), Manufactured for: Scherer Laboratories, Inc., Atlanta, GA 30339.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass ISinus 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.
Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IICVS Health, Original Strength, Triple Antibiotic Ointment Spray (bacitracin zinc 400 units, neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units per gram), 2 OZ (57 g) can, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Product#957603, UPC 0 50428 29525 0.
Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIMushatt'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.
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.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IICeraVe Healing Lip Balm/SPF 30 (avobenzone 3%, dimethicone 1%, homosalate 10%, octisalate 5%, octocrylene 10%, Net Wt. 0.15 oz. (4.25 g) stick, CeraVe LLC., New York, NY 10001, UPC 3 01872 49201 7.
Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIICicatricure, 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.
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIIWell 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.
Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIPremier Value, Fast Relief, Muscle Rub, (menthol 10% and methyl salicylate 15%) 4 OZ (113 g) tube, Distributed By: Chain Drug Consortium, 3301 NW Boca Raton Blvd., Suite 101, Boca Raton, FL, 33431, UPC 8 40986 01341
Superpotent Drug: high out of specification assay results for the menthol ingredient.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIRite Aid Pharmacy, First Aid Antibiotic Ointment, (neomycin sulfate 3.5 mg, polymyxin B sulfate 5,000 units, bacitracin zinc 400 units per gram), 2 OZ (56 g) tube, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 55441 1.
Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIFREEZE IT (camphor 0.2% and menthol 3.5%) spray, 118.29 mL (4 fl. oz.) can, Distributed by: Expedite Products, Inc., Tampa, FL 33619 USA, UPC 8 56569 00203 6.
Superpotent Drug: high out of specification assay results for the camphor ingredient.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIdr. brandt, BB cream with signature FLEXITONE, SPF 30, 1 oz./30 g tube, Distributed by: Cosmetic Dermatology, Inc., Miami, FL 33172, UPC 6 63963 00828 7.
Failed Stability Specifications: separation of product and failure for actives.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIWalgreens, NO DRIP Severe Anefrin Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength, 12 Hour + Menthol, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7001-01, UPC 3 11917 18536 1.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIWalgreens, NO DRIP, Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decongestant, Original, 12 Hour, Maximum Strength, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015,NDC 0363-7005-01, UPC 3 11917 18537 8.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIWell at Walgreens, ULTRA FINE Sinus Relief Mist (Oxymetazoline HCl 0.05%) bottle, Sinus Reliever, Nasal Decongestant, 12 Hour Pump Mist, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7000-01, UPC 3 11917 18535 4.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIWalgreens, NO DRIP Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decongestant, Extra Moisturizing, 12 Hour, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7004-01, UPC 3 11917 18534 7.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIWalgreens, Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength, 12 Hour, 0.75 FL OZ (22 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, UPC 3 11917 18622 1.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIBest Choice, SALINE Nasal Spray (Sodium Chloride 0.65% Phenylcarbinol & Benzalkonium Chloride as Preservatives), 1.5 FL OZ (44 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave, Kansas City, KS 66106, UPC 0 70038 58487 2.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIBest Choice, 12 Hour No-Drip 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 59895 4.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIBest Choice, 12 Hour Sinus Relief, 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 63684 7.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIBest 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.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIOCEAN Saline Nasal Spray, packaged in a) 3.5 Fl. Oz. (104 mL) bottle UPC 3 01875 26001 9; b) 45 cc (1.5 fl. oz.) UPC 3 01875 26003 3, c) Buddy Pack containing one 1.5 FL. OZ. (44 mL) and one 0.76 FL.OZ. (22 mL) bottle per carton, Distributed by: Valeant Consumer Products, A Division of Valeant Pharmaceuticals, North America LLC, Bridgewater, NJ 08807.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IITopCare, 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.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIThayers 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.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIThayers Natural Remedies, Saline Nasal Mist, Allergy & Sinus Relief, Slippery Elm, 3 FL OZ (89 mL) can, Distributed By: Product Quest Manufacturing, LLC, 330 Carswell Ave., Daytona Beach, FL 32117, UPC 7 27510 00659 8.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIRite Aid Pharmacy, nasal relief NO DRIP PUMP SPRAY nasal spray, (oxymetazoline hydrochloride 0.05%), 12 Hour, 1 FL OZ (30 mL) bottle, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 31412 1.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
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