Pharmaceutical Recalls Rosemont and Mylan Bromocriptine Mesylate
June 16, 1999
Englewood Cliffs, NJ (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that UDL Laboratories, Inc. is recalling Bromocriptine
Mesylate because of a lack of assurance of bioequivalence.
The recalled Bromocriptine Mesylate, USP, is a
prescription used to reduce tumor size prior to performing surgeries. The recalled
a) Bromocriptine Mesylate Tablets 2.5 mg, in 30 and 100 count bottles, under the
Rosemont and Mylan labels;
b) Bromocriptine Mesylate Capsules 5 mg, in 30 and 100 count bottles under the
All lots within expiration date.
Lek Pharmaceutical and Chemical Company, Ljubijana, Slovenia.
Lek, USA Englewood Cliffs, New Jersey, by telephone and fax on March 9, 1999, and
by letter dated April 1, 1999. Firm-initiated recall ongoing.
a) 6,678,000 bottles; b) 881,000 bottles were distributed.