December 26, 2000Triple Sulfa Vaginal Cream, USP
NC (SafetyAlerts) - The Food and
Drug Administration (FDA) said today that Alpharma USPD, Inc. is recalling Triple Sulfa
Vaginal Cream, USP because of subpotency of sulfacetamide at 12 month stability
This is the first public notice of
this Class III
recall issued by FDA.
Triple Sulfa Vaginal Cream, USP (Sulfathiazole/Sulfacetamide/Sulfabenzamide), in
2.75-ounce tube, Rx under the Alpharma label. NDC #0472-0700-78.
Lot #L908034 EXP 2/01.
Alpharma USPD, Inc., Lincolnton, North Carolina.
Manufacturer, by letter on or about September 25, 2000, and letter dated November 3, 2000.
Firm-initiated recall ongoing.
Nationwide, Puerto Rico, Canada.
37,265 units were distributed.
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 December
26, 2000. For more information regarding the SafetyAlerts free email alert service
please click here.
comprehensive safety recall information for the United States. SafetyAlerts Newsletter is a free email service to warn
consumers of faulty products and contaminated foods. For complete information regarding
current recalls, past recalls and timely product warning notification visit: www.safetyalerts.com.