9 FDA recalls mention Calcitriol. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Calcitriol.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Reason Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
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 Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at the 9 month stability time point
Reason Labeling: Label Mixup: CALCITRIOL, Capsule, 0.25 mcg may be potentially as one of the following drugs: ANAGRELIDE HCL, Capsule, 0.5 mg, NDC…
Reason Labeling:Label Mixup; CALCITRIOL, Capsule, 0.5 mcg may be potentially mislabeled as NIACIN TR, Tablet, 250 mg, NDC 10939043533, Pedigree: W003756…
Reason Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility…
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