Class II · Moderate risk
CVS Health
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Allergy & Cold Medication Recalls
Recalls of antihistamines, decongestants and nasal sprays.
314 recalls in this category, newest first.
Class II · Moderate risk
CVS Health
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk
Dymista (azelastine hydrochloride and fluticasone propionate)
Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Class II · Moderate risk
Fluticasone propionate Nasal Spray
Presence of foreign substance: glass particles
Class II · Moderate risk
Fluticasone propionate USP
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
Diphenhydramine HCl USP f
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class III · Low risk
Azelastine HCl Nasal Solution
Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station
Class II · Moderate risk
Maximum Strength Zephrex-D
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Doctor Manzanilla Cough & Cold
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
Doctor Manzanilla Allergy & Decongestant Relief
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class II · Moderate risk
NasalCrom (cromolyn sodium)
CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
Class III · Low risk
Children's Cetirizine Hydrochloride Chewable Tablets
Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
Class III · Low risk
Allergy Relief Diphenhydramine HCl 25 mg
Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.
Class III · Low risk
Diphenhydramine HCl 25 mg
Subpotent
Class III · Low risk
Azelastine Hydrochloride Nasal Solution
Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Class III · Low risk
Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg)
Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.
Class II · Moderate risk
Itraconazole 0.2%/Mupirocin 0.2%/Triamcinolone 0.03% Nasal Spray
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
Itraconazole 0.2%/Mupirocin 0.2% Nasal Spray
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
All cetirizine Products
Lack of Processing Controls
Class III · Low risk
Cetirizine HCl 10 mg Tablet
Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
Class III · Low risk
Meijer Loratadine Orally Disintegrating Tablets
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk
Wal-itin Loratadine Orally Disintegrating Tablets
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk
Sunmark loratadine Orally Disintegrating Tablets
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk
Up&Up loratadine orally disintegrating tablets
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk
Safeway Care Loratadine Orally Disintegrating Tablets
Superpotent Drug: Out Of Specification (OOS) result for Assay.
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