December 18, 2002
Recall Update: Syntho Pharmaceuticals
SYNTEST H.S. Recall is Complete
The Food and Drug
Administration (FDA) released the following information.
SYNTEST H.S. (Half Strength Tablets), (Esterified estrogens 0.625mg
and Methyltestosterone 1.25mg), 100 Tablet bottles, Rx only. Recall #
Lot S02D02, expiration date 3/2004
NDC # 66576-230-01.
Syntho Pharmaceuticals, Inc., Farmingdale, NY, by telephone on/about May 7,
initiated recall is complete.
Mislabeling; package insert incorrectly indicates dosage strength of Syntest
D.S. as 2.5mg
of Esterified Estrogens and 5mg Methyltestosterone rather than correctly as
Estrogens and 2.5mg Methyltestosterone.
VOLUME OF PRODUCT IN COMMERCE
10,008 bottles (100 tablets per bottle).