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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
October 28, 1998

PRODUCT
Nystatin Tablets, USP, Oral, 500,000 units, in 100 and 500 tablet bottles, Rx, intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis, under the Par, Qualitest, Major, and H.L. Moore labels. NDC # 49884-119-01 and 49884-119 -05 (Par); 0603-4830-21 (Qualitest); 0904-0672-60 (Major); 0839 -6282-06 (H.L. Moore). Recall #D-005-9.

CODE
Bulk Lot #    EXP Date    Lot Numbers

003740        1/99         004519, 004520, 004521, 004522
003754        2/99         005282, 005283, 005284, 005285
004744        3/99         005374, 005375, 005810, 005820
005571        4/99         006967, 006968, 006969, 006970
006018        5/99         007024, 007025, 007026, 007495
                                  007852, 007866, 007101, 011097
007032        9/99         008521, 008656, 008657, 008963
                                  009206
007042        8/99         009859, 009860, 009861
009891       10/99         011098, 011100, 011101.

MANUFACTURER
Par Pharmaceutical, Inc., Spring Valley, New York.

RECALLED BY
Manufacturer, by letter on October 5, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Puerto Rico.

QUANTITY
77,000 bottles of 100s and 206 bottles of 500s were distributed.

REASON
Subpotent.

 

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.