Class II · Moderate risk Terminated
Colchicine Capsules 0.6 mg
Reason Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
COLCHICINE Tablet
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Mixup; COLCHICINE Tablet, 0.6 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: AD46312_37, EXP: 5/16/2014; PSEUDOEPHEDRINE HCL, Tablet, 30 mg, NDC 00904505360, Pedigree: AD52993_37, EXP: 5/20/2014; SENNOSIDES, Tablet, 8.6 mg, NDC 00182109301, Pedigree: AD62992_14, EXP: 5/23/2014; CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904
What was recalled
COLCHICINE Tablet, 0.6 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64764011907
- Recalling firm
- Aidapak Services, LLC
- Origin
- WA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-696-2014
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.
Other Colchicine recalls
See all
Class III · Low risk Terminated
Colchicine Tablets
Reason Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.
Class II · Moderate risk Terminated
Colcrys
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
Colchicine 0.6 mg Caps
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk Terminated
Colchicine active pharmaceutical ingredient packaged in varying…
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 were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
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