The Food and Drug Administration (FDA) released the following information.

PRODUCT
Amiloride Hydrochloride Tablets, USP, 5 mg, 100 tablet bottles, Rx only. Recall # D-277-3.

CODE
Lot 035607; Expiration Date: 12/2004.

RECALLING FIRM/MANUFACTURER
Par Pharmaceutical, Spring Valley, NY, by letters on May 30, 2003. Firm initiated recall is ongoing.

REASON
Mislabeled; Bottle labeled as containing 5 mg Amiloride Hydrochloride tablets actually contains Minoxidil 2.5 mg tablets.

VOLUME OF PRODUCT IN COMMERCE
4,821/100 count bottles.

DISTRIBUTION
Nationwide.