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SafetyAlerts
June 16, 1999

Lek Pharmaceutical Recalls Rosemont and Mylan Bromocriptine Mesylate

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 products are:
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 Rosemont label.

CODE
All lots within expiration date.

MANUFACTURER
Lek Pharmaceutical and Chemical Company, Ljubijana, Slovenia.

RECALLED BY
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.

DISTRIBUTION
Colorado.

QUANTITY
a) 6,678,000 bottles; b) 881,000 bottles were distributed.

Recall #D-245/246-9.

 

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.