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SafetyAlerts
November 19,  2003

Syntho Pharmaceuticals Has Recalled SYNTEST

(SafetyAlerts) - The FDA has released the following information.

 

PRODUCT
a) SYNTEST H.S. (Half-Strength Tablets), EACH TABLET
CONTAINS: Esterified Estrogens .625mg/Methyltestosterone
1.25mg, 100 Tablet bottles, Syntho, Rx only.
Recall # D-063-4;
b) SYNTEST D.S. (Double-Strength Tablets), EACH TABLET
CONTAINS: Esterified Estrogens 1.25 g/Methyltestosterone
2.5 mg, 100 Tablet bottles. Recall # D-064-4.

CODE
a) Lot Nos: S02D02 (exp. date 03/04),
S02D03 (exp. date 03/04), S02K02 (exp. date 09/04),
S02K03 (exp. date 09/04), S02K10 (exp. date 09/04);
b) Lot No. S02D01 (exp. date 03/04).

RECALLING FIRM/MANUFACTURER
Syntho Pharmaceuticals, Inc., Farmingdale, NY, by letter dated October 13, 2003. FDA initiated recall is ongoing.

REASON
Subpotency: finished product and/or content uniformity testing.

VOLUME OF PRODUCT IN COMMERCE
59,693 bottles of 100 tablets in total.

DISTRIBUTION
Nationwide.

 
Selected Recent Recalls


Health Professional:

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

How many did you hear about?

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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.