FDA (Drugs) recall action 80750

Product Quest Manufacturing LLC recalled 54 products on 2018-10-24

The FDA (Drugs) publishes a recall like this one as 54 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 54 pages.

Products: 54
Announced: 2018-10-24
Critical: 1
Units: 7,981,021

Why these products were recalled

Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.

CGMP Deviations: products manufactured under conditions that could impact its product quality.

Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–25 of 54

LowFDA (Drugs)··2018-10-24
Well at Walgreens Scar Cream Recalled for Low Active Ingredient Levels
Product Quest Manufacturing LLC is recalling 6,516 tubes of Well at Walgreens Scar Cream with SPF 30 because the octocrylene and avobenzone levels were found to be lower than required.
Product
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.
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ModerateFDA (Drugs)··2018-10-24
FDA Recalls Best Choice Nasal Spray Due to Manufacturing Deviations
Product Quest Manufacturing LLC is recalling Best Choice Nasal Spray because it was manufactured under conditions that could impact product quality.
Product
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.
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CriticalFDA (Drugs)··2018-10-24
CVS Sinus Relief Nasal Spray Recalled for Pseudomonas Contamination
Product Quest Manufacturing LLC is recalling CVS-branded Sinus Relief nasal spray due to failed microbiological testing for Pseudomonas aeruginosa.
Product
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.
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ModerateFDA (Drugs)··2018-10-24
CVS Saline Nasal Gel Recalled for Manufacturing Quality Deviations
Product Quest Manufacturing LLC is recalling CVS Health Saline Nasal Gel with Soothing Aloe due to manufacturing conditions that could impact product quality.
Product
CVS Health, Saline Nasal Gel with Soothing Aloe, packaged as a) Baby Net Wt. 0.5 OZ (14.2 g) tube UPC 0 50428 58392 0 Product #282476; and b) Net Wt. 0.5 OZ tube (14.2 g) UPC 0 50428 31746 4 Product #896071; Distributed by CVS Pharmacy, Inc,. One CVS Drive, Woonsocket, RI 02895.
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HighFDA (Drugs)··2018-10-24
FDA Recalls Premier Value Nasal Decongestant Due to Manufacturing Deviations
Product Quest Manufacturing LLC is recalling Premier Value Nasal Decongestant due to CGMP deviations that could impact product quality.
Product
Premier 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…
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ModerateFDA (Drugs)··2018-10-24
Product Quest Recalls Dr. Brandt BB Cream for Stability Failures
Product Quest Manufacturing LLC is recalling 9,480 tubes of Dr. Brandt BB Cream with SPF 30 due to failed stability specifications, including product separation.
Product
dr. 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.
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ModerateFDA (Drugs)··2018-10-24
Product Quest Recalls Best Choice Saline Nasal Spray for Quality Deviations
Product Quest Manufacturing LLC is recalling Best Choice Saline Nasal Spray because it was manufactured under conditions that could impact product quality.
Product
Best 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.
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ModerateFDA (Drugs)··2018-10-24
Rhinall Nasal Decongestant Spray Recalled for Manufacturing Quality Deviations
Product Quest Manufacturing LLC is recalling Rhinall Nasal Decongestant Nasal Spray due to manufacturing conditions that could impact product quality.
Product
Rhinall Nasal Decongestant Nasal Spray (phenylephrine HCl), 0.25%, 1 1/3 Fl Oz. (40 ml), Manufactured for: Scherer Laboratories, Inc., Atlanta, GA 30339.
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ModerateFDA (Drugs)··2018-10-24
QC Quality Choice Saline Nasal Gel Recalled for Quality Deviations
Product Quest Manufacturing LLC is recalling QC Quality Choice Saline Nasal Gel with Soothing Aloe due to manufacturing deviations that could impact product quality.
Product
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.
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ModerateFDA (Drugs)··2018-10-24
Rexall Sinus Nasal Pump Mist Recalled for Quality Control Issues
Product Quest Manufacturing LLC is recalling Rexall Sinus Nasal Pump Mist due to manufacturing deviations that could impact product quality.
Product
Rexall, Sinus Nasal Pump Mist, (Oxymetazoline Hydrochloride 0.05%), 1 FL OZ (30mL) bottle, SKU 00744201
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SevereFDA (Drugs)··2018-10-24
CeraVe Healing Lip Balm Recalled for Staphylococcus Aureus Contamination
Product Quest Manufacturing LLC is recalling CeraVe Healing Lip Balm/SPF 30 due to failed microbiological testing for Staphylococcus aureus.
Product
CeraVe 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.
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ModerateFDA (Drugs)··2018-10-24
Rite Aid Nasal Spray Recalled for Manufacturing Quality Deviations
Product Quest Manufacturing LLC is recalling Rite Aid nasal spray due to manufacturing conditions that could impact product quality.
Product
Rite 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.
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SevereFDA (Drugs)··2018-10-24
Harmon Face Values Saline Nasal Gel Recalled for Quality Deviations
Product Quest Manufacturing LLC is recalling Harmon Face Values Saline Nasal Gel with Soothing Aloe due to manufacturing deviations that could impact product quality.
Product
Harmon 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 .
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ModerateFDA (Drugs)··2018-10-24
Walgreens Severe Anefrin Nasal Spray Recalled for Quality Deviations
Product Quest Manufacturing LLC is recalling Walgreens NO DRIP Severe Anefrin Nasal Spray due to manufacturing deviations that could impact product quality.
Product
Walgreens, 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.
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SevereFDA (Drugs)··2018-10-24
Dermatone Sunscreen Stick Recalled for Staphylococcus Aureus Contamination
Product Quest Manufacturing LLC is recalling Dermatone No-Touch Sunscreen Sticks because samples tested positive for Staphylococcus aureus.
Product
DERMATONE (titanium oxide 6% and zinc oxide 4.7%) No-Touch Sunscreen Stick, SPF 50, Net Wt. 0.49 oz. (13.9g) stick, Distributed by: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 0 20908 05100 3.
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HighFDA (Drugs)··2018-10-24
Thayers Saline Nasal Spray Recalled for Manufacturing Quality Deviations
Product Quest Manufacturing is recalling Thayers Saline Nasal Spray due to manufacturing conditions that could impact product quality.
Product
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.
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ModerateFDA (Drugs)··2018-10-24
Rhinall Nasal Decongestant Recalled for Manufacturing Quality Deviations
Product Quest Manufacturing LLC is recalling Rhinall nasal drops due to CGMP deviations that could impact product quality.
Product
Rhinall (phenylephrine hydrochloride) Nasal Decongestant Nose Drops, 0.25%, 1 FL OZ (30 mL) bottle, Distributed by: Scherer Labs International, LLC., 330 Carswell Ave., Daytona Beach, FL 32117, UPC 3 02747 52531 1.
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ModerateFDA (Drugs)··2018-10-24
Thayers Saline Nasal Mist Recalled for Manufacturing Quality Deviations
Product Quest Manufacturing is recalling Thayers Saline Nasal Mist due to manufacturing conditions that could impact product quality.
Product
Thayers 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.
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ModerateFDA (Drugs)··2018-10-24
Product Quest Recalls Meijer Saline Nasal Spray Due to Quality Deviations
Product Quest Manufacturing LLC is recalling Meijer Saline Nasal Spray because it was manufactured under conditions that could impact product quality.
Product
meijer, 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 .
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ModerateFDA (Drugs)··2018-10-24
Product Quest Recalls HuMist Saline Nasal Mist Due to Manufacturing Deviations
Product Quest Manufacturing LLC is recalling HuMist Saline Nasal Mist bottles due to manufacturing deviations that could impact product quality.
Product
HuMist 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 .
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ModerateFDA (Drugs)··2018-10-24
Rexall Nasal Spray Recalled for Manufacturing Quality Deviations
Product Quest Manufacturing LLC is recalling Rexall Extra Moisturizing No Drip Nasal Spray due to CGMP deviations that could impact product quality.
Product
Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48/3/1 #12687901 w/ Silo
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HighFDA (Drugs)··2018-10-24
Meijer Sterile Saline Nasal Mist Recalled for Quality Control Issues
Product Quest Manufacturing LLC is recalling Meijer Sterile Saline Nasal Mist cans due to manufacturing deviations that could impact product quality.
Product
Meijer, 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.
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SevereFDA (Drugs)··2018-10-24
Product Quest Recalls Well at Walgreens Sinus Relief Mist for Quality Issues
Product Quest Manufacturing LLC is recalling Well at Walgreens ULTRA FINE Sinus Relief Mist due to manufacturing deviations that could impact product quality.
Product
Well 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.
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ModerateFDA (Drugs)··2018-10-24
Harmon Face Values Saline Nasal Spray Recalled for Quality Deviations
Product Quest Manufacturing LLC is recalling Harmon Face Values Saline Nasal Spray due to manufacturing deviations that could impact product quality.
Product
Harmon 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.
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ModerateFDA (Drugs)··2018-10-24
Rite Aid First Aid Antibiotic Ointment Recalled for Low Bacitracin Zinc
Product Quest Manufacturing LLC is recalling Rite Aid First Aid Antibiotic Ointment because the bacitracin zinc ingredient was found to be subpotent.
Product
Rite 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.
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