May 24, 2001Spear Pharmaceuticals Recalls
Certain Batches of Geneva Tretinoin Gel
FL (SafetyAlerts) - The Food and
Drug Administration (FDA) said today that Spear Pharmaceuticals is recalling certain
batches of its Geneva Tretinoin
Gel because of viscosity failure (3 month stability station).
This is the first public notice of
this Class III
recall issued by FDA.
a) Geneva Tretinoin Gel, USP, 0.025%, NDC 0781-7061-27, Batch #PMIP NET WT. 15 G
b) Geneva Tretinoin Gel, USP, 0.025%, NDC 0781-7061-19, Batch #PMIP-1 NEW WT. 45 G
(15 gm) Batch # PMIP, Exp 11/02;
(45 gm) Batch # PMIP-1, Exp 11/02.
DPT LABORATORIES, SAN ANTONIO,TX.
Spear Pharmaceuticals, Titusville, FL., on 4/30/2001 by letter. Firm-initiated recall
12,336 bottles of 15gm;
15,852 bottles of 45gm.
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 May 24,
2001. For more information regarding the SafetyAlerts free email alert service
please click here.