Class II · Moderate risk Completed
Camber Pharmaceuticals
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Completed
Camber Pharmaceuticals
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Completed
Camber Pharmaceuticals
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Completed
Camber Pharmaceuticals
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Doxycycline Hyclate USP Tablets
Reason Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.
Class II · Moderate risk Terminated
PIO&METFORMIN 15/1000 mg Tab 1
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended Release Tablets 1000 mg
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended Release Tablets 1000 mg
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended Release Tablets
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk Terminated
Fortamet
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk Terminated
Paliperidone Extended Release Tablets 9 mg
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk Terminated
Paliperidone Extended Release Tablets 3 mg
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk Terminated
Family Dollar Saline Nasal Spray 4.25 oz. can
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk Terminated
Finafta Baby
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk Terminated
Rexall
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk Terminated
Rexall
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk Terminated
Rexall
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk Terminated
Rhinall Nasal Decongestant Nasal Spray
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk Terminated
CVS Health
Reason Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
Class II · Moderate risk Terminated
Mushatt's No. 9
Reason Microbial Contamination of Non-Sterile Products and Subpotent Drug: failure for microbiological growth exceeding specification and low out of specification assay results for salicylic acid.
Class II · Moderate risk Terminated
CeraVe Healing Lip Balm/SPF 30
Reason Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.
Class II · Moderate risk Terminated
Premier Value
Reason Superpotent Drug: high out of specification assay results for the menthol ingredient.
Class II · Moderate risk Terminated
Rite Aid Pharmacy
Reason Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
Class II · Moderate risk Terminated
Freeze It
Reason Superpotent Drug: high out of specification assay results for the camphor ingredient.
Class II · Moderate risk Terminated
dr. brandt
Reason Failed Stability Specifications: separation of product and failure for actives.