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Allergy & Cold Medication Recalls

Recalls of antihistamines, decongestants and nasal sprays.

320 recalls in this category, newest first.

Class II · Moderate risk Terminated Oct 19, 2018

children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL)…

Reason Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.

Taro Pharmaceuticals U.S.A., Inc. NDC 56062-106-08 D-0277-2019

Class II · Moderate risk Terminated Oct 19, 2018

Children's 24 Hour Allergy (cetirizine hydrochloride) Oral Solution 1 mg/mL, Bubble Gum Flavor, Sugar Free/Dye Free, 4 FL OZ (120…

Reason Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.

Taro Pharmaceuticals U.S.A., Inc. NDC 41250-106-08 D-0276-2019

Class III · Low risk Terminated Sep 10, 2018

Calcium Gluconate 2.5% a) 250 mL 25 mg/mL NDC 69699-0908-25; b) Nasal Spray 2.5 Inhal Soln. NDC 69699-0908-10; c) Nebulization…

Reason Lack of Assurance of Sterility

Pharm D Solutions, LLC NDC 69699-0908-25 D-0149-2019

Class II · Moderate risk Terminated Aug 3, 2018

Family Dollar Saline Nasal Spray 4.25 oz. can, 24 pk, SKU 0900562.

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

Product Quest Manufacturing LLC D-0080-2019

Class II · Moderate risk Terminated Aug 3, 2018

Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48 pk. (12687901)

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

Product Quest Manufacturing LLC D-0078-2019

Class II · Moderate risk Terminated Aug 3, 2018

Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48/3/1 #12687901 w/…

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

Product Quest Manufacturing LLC D-0077-2019

Class II · Moderate risk Terminated Aug 3, 2018

Rhinall Nasal Decongestant Nasal Spray (phenylephrine HCl), 0.25%, 1 1/3 Fl Oz. (40 ml), Manufactured for: Scherer Laboratories…

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

Product Quest Manufacturing LLC D-0075-2019

Class II · Moderate risk Terminated Aug 3, 2018

Walgreens, NO DRIP Severe Anefrin Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength, 12 Hour + Menthol…

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

Product Quest Manufacturing LLC NDC 0363-7001-01 D-0064-2019

Class II · Moderate risk Terminated Aug 3, 2018

Walgreens, NO DRIP, Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decongestant, Original, 12 Hour, Maximum Strength, 0.5…

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

Product Quest Manufacturing LLC NDC 0363-7005-01 D-0063-2019

Class II · Moderate risk Terminated Aug 3, 2018

Walgreens, NO DRIP Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decongestant, Extra Moisturizing, 12 Hour, 0.5 FL OZ (15…

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

Product Quest Manufacturing LLC NDC 0363-7004-01 D-0061-2019

Class II · Moderate risk Terminated Aug 3, 2018

Walgreens, Nasal Spray (Oxymetazoline HCl 0.05%) Nasal Decongestant, Maximum Strength, 12 Hour, 0.75 FL OZ (22 mL) bottle…

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

Product Quest Manufacturing LLC D-0060-2019

Class II · Moderate risk Terminated Aug 3, 2018

Best Choice, SALINE Nasal Spray (Sodium Chloride 0.65% Phenylcarbinol & Benzalkonium Chloride as Preservatives), 1.5 FL OZ (44…

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

Product Quest Manufacturing LLC D-0059-2019

Class II · Moderate risk Terminated Aug 3, 2018

Best Choice, 12 Hour No-Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) Nasal Decongestant, 1 FL OZ (30 mL) bottle, Proudly…

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

Product Quest Manufacturing LLC D-0058-2019

Class II · Moderate risk Terminated Aug 3, 2018

Best Choice, 12 Hour Sinus Relief, Nasal Spray (Oxymetazoline Hydrochloride 0.05%) Nasal Decongestant, 1 FL OZ (30 mL) bottle…

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

Product Quest Manufacturing LLC D-0057-2019

Class II · Moderate risk Terminated Aug 3, 2018

Best Choice, 12 Hour Extra Moisturizing, Nasal Spray (Oxymetazoline Hydrochloride 0.05%), Nasal Decongestant, 1 FL OZ (30 mL)…

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

Product Quest Manufacturing LLC D-0056-2019

Class II · Moderate risk Terminated Aug 3, 2018

OCEAN 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…

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

Product Quest Manufacturing LLC D-0055-2019

Class II · Moderate risk Terminated Aug 3, 2018

Thayers Natural Remedies, Saline Nasal Spray, Allergy & Sinus Relief, Slippery Elm, 1.5 FL OZ (44 mL) bottle, Distributed By…

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

Product Quest Manufacturing LLC D-0053-2019

Class II · Moderate risk Terminated Aug 3, 2018

Rite Aid Pharmacy, nasal relief NO DRIP PUMP SPRAY nasal spray, (oxymetazoline hydrochloride 0.05%), 12 Hour, 1 FL OZ (30 mL)…

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

Product Quest Manufacturing LLC D-0051-2019

Class II · Moderate risk Terminated Aug 3, 2018

QC Quality Choice, Saline Nasal Relief, Moisturizing Nasal Spray, Sodium Chloride 0.65%, packaged as a) 1.5 FL OZ (45 mL) bottle…

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

Product Quest Manufacturing LLC D-0050-2019

Class II · Moderate risk Terminated Aug 3, 2018

Premier Value, Saline Nasal Spray, Sodium Chloride 0.65%, packaged as a) 3 FL OZ (88 mL) bottle NDC 68016-388-00 UPC 8 40986…

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

Product Quest Manufacturing LLC NDC 68016-388-00 D-0048-2019

Class II · Moderate risk Terminated Aug 3, 2018

Premier Value, Nasal Decongestant, Nasal Spray (oxymetazoline HCl 0.05%), Regular Strength, 1 FL OZ (30 mL) bottle, Distributed…

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

Product Quest Manufacturing LLC NDC 68016-316-03 D-0047-2019

Class II · Moderate risk Terminated Aug 3, 2018

Premier Value, Nasal Decongestant, No Drip Nasal Spray (oxymetazoline HCl) Nasal Solution, 12 Hour Pump Mist, Maximum Strength, 1…

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

Product Quest Manufacturing LLC NDC 68016-308-03 D-0045-2019

Class II · Moderate risk Terminated Aug 3, 2018

Premier Value Nasal Decongestant Extra Moisturizing Nasal Spray (Oxymetazoline HCl 0.05%), 1 FL OZ (30 mL) bottle, Distributed By…

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

Product Quest Manufacturing LLC NDC 68016-304-03 D-0044-2019

Class II · Moderate risk Terminated Aug 3, 2018

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…

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

Product Quest Manufacturing LLC D-0041-2019

Class II · Moderate risk Terminated Aug 3, 2018

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)…

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

Product Quest Manufacturing LLC D-0040-2019