Simvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-004-15, UPC 3 16729 00415 2; b) 1,000-count…
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Recalls of statins and other lipid-lowering drugs used to manage high cholesterol.
161 recalls in this category, newest first.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
Reason Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity…
Reason Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity…
Reason Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Reason Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Reason Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Reason Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Reason Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
Reason Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Reason Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
Reason Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing…
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