Recalls of antihistamines, decongestants and nasal sprays.
320 recalls in this category, newest first.
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Reason Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Reason Presence of foreign substance: glass particles
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Reason 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…
Reason Microbial Contamination of Non-Sterile Products
Reason CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Reason CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Reason CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
Reason Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.
Reason Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.
Reason Subpotent
Reason Defective Delivery System: out of specification result for droplet size distribution at the d90 measurement testing during the 6 month time point..
Reason Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient…
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Reason Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Reason Lack of Processing Controls
Reason Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
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