Drug and pharmaceutical recalls
17624 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 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.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIQC Quality Choice, Saline Nasal Relief, Moisturizing Nasal Spray, Sodium Chloride 0.65%, packaged as a) 1.5 FL OZ (45 mL) bottle UPC 6 35515 98845 3; b) 3 FL OZ (89 mL) bottle UPC 6 35515 95042 9, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIQC 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.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIPremier Value, Saline Nasal Spray, Sodium Chloride 0.65%, packaged as a) 3 FL OZ (88 mL) bottle NDC 68016-388-00 UPC 8 40986 01483 3; b) 1.5 FL OZ (44 mL) bottle NDC 68016-466-00 UPC 8 40986 01482 6, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIPremier Value, Nasal Decongestant, Nasal Spray (oxymetazoline HCl 0.05%), Regular Strength, 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-316-03, UPC 8 40986 01516 8.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIPremier Value, Sterile Saline Nasal Mist, Saline Nasal Moisturizer (0.9% Sodium Chloride) Solution, 4.25 FL OZ (126 mL) can, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 8 40986 02998 1.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIPremier Value, Nasal Decongestant, No Drip Nasal Spray (oxymetazoline HCl) Nasal Solution, 12 Hour Pump Mist, Maximum Strength, 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-308-03, UPC 8 40986 01519 9.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIPremier Value Nasal Decongestant Extra Moisturizing Nasal Spray (Oxymetazoline HCl 0.05%), 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-304-03, UPC 8 40986 01518 2.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIHuMist Saline Nasal Mist 1.5 FL OZ (45 mL) bottle, Distributed by: Scherer Labs International, LLC. 330 Carswell Ave., Daytona Beach, FL 32117, UPC 3 02742 68045 9 .
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIMeijer, Sterile Saline Nasal Mist (0.9% Sodium Chloride Solution), 4.25 OZ (120 g) can, Dist. By Meijer Distribution, Inc., 2929 Walker Ave. NW, Grand Rapids, MI 49544, UPC 7 13733 27615 3.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IImeijer, Saline Nasal Spray, Nasal Moisturizing Spray, packaged as a) 1.5 FL OZ (44 mL) UPC 7 08820 74428 8; b) 3FL OZ (88 mL) UPC 7 08820 74430 1, Dist. By Meijer Distribution, Inc., Grand Rapids, MI 49544 .
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIHarmon Face Values, Saline Nasal Spray (sodium chloride), 0.65%, packaged as a) 1.5 FL OZ (44 mL) bottle UPC 7 27510 00501 0; b) 3 FL OZ (88 mL) bottle UPC 7 27510 00502 7, Distributed by Harmon Stores, Inc., Union, NJ 07083 USA.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIHarmon Face Values, Saline Nasal Gel with Soothing Aloe, 0.5 oz. (14.1 g) tube, Distributed by: Harmon Stores, Inc., Union, NJ 07083 USA, UPC 7 27510 00474 7 .
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIFAMILY wellness, Sterile Saline, Nasal Mist, Saline Nasal Relief (0.9% Sodium Chloride Solution), 4.25 FL OZ (126 mL) can, Distributed by: Midwood Brands, LLC, 10611 Monroe Rd., Matthews, NC 28105, UPC 0 32251 11617 9.
CGMP Deviations: products manufactured under conditions that could impact its product quality.
- 2018-10-24FDA-DrugProduct Quest Manufacturing LLCClass IIDG health, No Drip, Nasal Pump Mist (oxymetazoline hydrochloride), 0.05%, 1 FL OZ (30 mL) bottle, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072, UPC 7 27510 00373 3 .
CGMP Deviations: products manufactured under conditions that could impact its product quality.
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