June 21, 2001Two Companies Recall Counterfeit
CA (SafetyAlerts) - The Food and
Drug Administration (FDA) said today that two different companies have recalled certain
Serostim Vials because the drug is counterfeit.
This is the first public notice of
this Class II
recall issued by FDA.
Serostim Vial, 6 mg, (somatropin (rDNA origin) for injection), NDC 44087-0006-07,
cartons of 7.
Lot No: MNK612A.
RESPONSIBLE FIRM AND MANUFACTURER:
BERGEN BRUNSWIG DRUG CO., Orange, CA, by recall letter dated March 8, 2001. Firm initiated
recall is ongoing. Recall # D-224-1.
CA, HI, MD, TX, and WA (mostly in CA).
ALSO RECALLED BY:
C & H Wholesale, Inc., Davie, FL, by letter dated Jan 25, 2001. Firm-initiated recall
complete. Recall # D-223-1.
NJ and FL.
Questions concerning this recall may be directed
to the FDA at 1-888-INFO-FDA.
Notice of this product warning was sent via email
to SafetyAlerts subscribers June 21,
2001. For more information regarding the SafetyAlerts free email alert service
please click here.