Press Office
Food and Drug Administration
U.S. Department of Health and Human Services

PHYNE PHARMACEUTICALS IS NOT RECALLING ADRENAL CORTEX EXTRACT; PRODUCT REMAINS A CONCERN TO FDA

Phyne Pharmaceuticals Inc. has informed FDA that it is not recalling vials of injectable Adrenal Cortex Extract (ACE) manufactured by AMRAM Inc. FDA had included ACE in its January 25, 2001 press release about the Phyne Pharmaceuticals recall.

FDA shares the same safety concern about ACE as it does with the products which Phyne Pharmaceuticals is recalling because all of the products were manufactured by AMRAM Inc. under the same conditions violating good manufacturing standards for pharmaceuticals. Vials of ACE manufactured by AMRAM Inc. will bear AMRAM’s name on the label.

FDA strongly recommends this product not be used, and it be disposed of by being destroyed in such a manner rendering it unusable.

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