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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
June 3, 1998

PRODUCT
Atenolol Tablets; a synthetic beta-selective adrenoreceptor blocking agent for the management of hypertension; packaged in 100 & 1000 tablet bottles:

a) 50 mg, NDC #55953-039-40, -80, also packaged under the Major label, NDC #0904-7634-60, -80, Rugby label, Mfd for Rugby Laboratories, Inc., Norcross, Georgia, NDC #0536-3330-01, -10, Qualitest label, NDC #0603-2371-21, -32, Martec label, Mfd for Martec Pharmaceutical, Inc., Kansas City, MO, NDC #52555-531-01, -10 and Mova label, Mfd for Mova Pharmaceutical Corp., Caguas, PR 00725, NDC #55370-122-07

b) 100 mg, NDC #55953-401-40, also packaged under the Rugby label, NDC #0536-3331-01, Qualitest label, NDC #0603-2372-21, Martec label, NDC #52555-534-01, and Moore label, Distributed by Moore Drug Exchange, New Britain, Conn., NDC #0839-7724-06.

Recall #D-154/155-8.

CODE
All lots within expiration date.

MANUFACTURER
Novopharm Ltd., Scarborough, Ontario, Canada.

RECALLED BY
Novopharm USA, Inc., Schaumburg, Illinois, by letter dated May 8, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
Amount distributed:
a) 67,459 100-tablet and 49,858 1000-tablet bottles
b) 225,873 100-tablet bottles.

REASON
Lack of blend uniformity assurance.

 

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.