November 19, 2003
Syntho Pharmaceuticals Has Recalled
The FDA has released the following information.
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.
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).
Syntho Pharmaceuticals, Inc., Farmingdale, NY, by letter dated October 13,
2003. FDA initiated recall is ongoing.
Subpotency: finished product and/or content uniformity testing.
VOLUME OF PRODUCT IN COMMERCE
59,693 bottles of 100 tablets in total.