41 FDA recalls mention Simvastatin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Simvastatin.
Reason Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Reason Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Reason Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
Reason Presence of foreign substance: metallic razor blade was found in one bottle.
Reason Subpotent Drug
Reason Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets.
Reason Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Reason Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Reason Failed Impurities/Degradation Specifications: Product failed a known impurity specification.
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.
Reason Labeling: Label Mixup: SIMVASTATIN, Tablet, 40 mg may have potentially been mislabeled as the following drug: METOPROLOL TARTRATE, Tablet, 12.5 mg…
Reason Labeling: Label Mixup: SIMVASTATIN, Tablet, 5 mg may have potentially been mislabeled as the following drug: LOSARTAN POTASSIUM, Tablet, 25 mg, NDC…
Reason Labeling: Label Mixup; SIMVASTATIN Tablet, 20 mg may be potentially mislabeled as VITAMIN B COMPLEX WITH C/FOLIC ACID, Tablet, NDC 60258016001…
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