Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Operating Company, LLC., Gurnee, IL 60031. ALL NDCs
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: CALCITRIOL, Capsule, 0.25 mcg may be potentially as one of the following drugs: ANAGRELIDE HCL, Capsule, 0.5 mg, NDC 00172524160, Pedigree: AD46414_7, EXP: 5/16/2014; BENAZEPRIL HCL, Tablet, 5 mg, NDC 65162075110, Pedigree: AD52778_7, EXP: 5/20/2014; CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: W003615, EXP: 6/25/2014.
CALCITRIOL, Capsule, 0.25 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054000725.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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…
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