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SafetyAlerts
May 24, 2001

Spear Pharmaceuticals Recalls Certain Batches of Geneva Tretinoin Gel

Titusville, 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.

PRODUCT
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

Recall#D-213-1

CODE:
(15 gm) Batch # PMIP, Exp 11/02;
(45 gm) Batch # PMIP-1, Exp 11/02.

MANUFACTURER:
DPT LABORATORIES, SAN ANTONIO,TX.

RECALLED BY:
Spear Pharmaceuticals, Titusville, FL., on 4/30/2001 by letter. Firm-initiated recall ongoing.

DISTRIBUTION:
Nationwide.

QUANTITY:
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.

 
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Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.