notyard
08-16-2009, 12:24 AM
FDA class II recall:
PRODUCT
CycloSPORINE Capsules USP, 100 mg. 30 (3 x 10) UD blister pack, Rx only, NDC # 62584-827-21, Recall # D-1882-2009
CODE
Lot # 081488, Exp 01/10
RECALLING FIRM/MANUFACTURER
American Health Packaging, Columbus, OH, by letters on June 12, 2008. Manufacturer: Apotex Corp., Weston, FL. Firm initiated recall is ongoing.
REASON
This recall was initiated because ongoing monitoring has determined that the lot has a level of related compound marginally in excess of the specification limit.
VOLUME OF PRODUCT IN COMMERCE
377 units (3 x 10 count blister packs per unit)
DISTRIBUTION
Nationwide
PRODUCT
CycloSPORINE Capsules USP, 100 mg. 30 (3 x 10) UD blister pack, Rx only, NDC # 62584-827-21, Recall # D-1882-2009
CODE
Lot # 081488, Exp 01/10
RECALLING FIRM/MANUFACTURER
American Health Packaging, Columbus, OH, by letters on June 12, 2008. Manufacturer: Apotex Corp., Weston, FL. Firm initiated recall is ongoing.
REASON
This recall was initiated because ongoing monitoring has determined that the lot has a level of related compound marginally in excess of the specification limit.
VOLUME OF PRODUCT IN COMMERCE
377 units (3 x 10 count blister packs per unit)
DISTRIBUTION
Nationwide