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SafetyAlerts
December 14, 1999

G&W Laboratories Recalls Tebamide Suppositories

South Plainfield, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that G&W Laboratories is recalling Tebamide (tm) Suppositories (Trimethobenzamide), 200 mg, in boxes of 10 and 50. The product is a prescription used to control nausea and vomiting. G&W is recalling this product because of subpotency of Benzocaine and/or lack of assurance Benzocaine levels will remain within specification over labeled expiration date.

This Class III recall was initiated by the company, by letters on June 11, 1999, and August 25, 1999.  This is the first notice the FDA has issued to the general public of the recall.  The FDA considers this recall complete.

140,000 units were distributed in nationwide and can be identified as follows:

Lot number 7025-5  expiration date 02/00:
NDC# 0713-0108-50 G & W (50s)
NDC# 0713-0108-09 G & W (10s)
NDC# 0904-2736-15 Major (I Os)
NDC# 0364-7348-10 Schein (I Os)

Lot number 7072-5 expiration date 03/00:
NDC# 0713-0108-09 G & W (10s)
NDC# 0904-2736-15 Major (I Os)
NDC# 0364-7348-10 Schein (1 Os)

Lot number 7226-2 expiration date 09/00:
NDC# 0713-0108-09 G & W (10s)
NDC# 0364-7348-10 Schein (I Os)

Lot number 8173-1 expiration date 07/01:
NDC# 0713-0108-09 G & W (10s)
NDC# 0713-0108-50 G & W (50s)
NDC# 0904-2736-15 Major (I Os)
NDC# 0364-7348-10 Schein (I Os)

Lot number 8173-2 expiration date 07/01:
NDC# 0713-0108-09 G & W (10s)
NDC# 0713-0108-50 G & W (50s)

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

 
Selected Recent Recalls


Health Professional:

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

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