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SafetyAlerts
March 14, 2002

Prometheus Has Recalled Trandate Tablets

San Diego, CA (SafetyAlerts) - The Food and Drug Administration (FDA) said that Prometheus has recalled Trandate Tablets (labetalol hydrochloride), 300 mg, packaged in 100 unit bottles and 100 unit dose packages (10x10 tablets).

PRODUCT
Trandate Tablets (labetalol hydrochloride), 300 mg,
packaged in 100 unit bottles and 100 unit dose packages
(10x10 tablets). Indicated in the management of hypertension. Recall # D-204-2.

CODE
a) Lot OZP1108 (300 mg X 100s);
b) Lot 9ZM2082A (300 mg X 100 UD).

RECALLING FIRM/MANUFACTURER
Recalling Firm: Prometheus, San Diego, CA, by letter sent February 19, 2002.

Manufacturer: Glaxo Welcome, Zebulon, NC. Firm initiated recall is ongoing.

REASON
Dissolution Failure (at stability testing).

VOLUME OF PRODUCT IN COMMERCE
a) 5224 mfd., 5179 dist., 45 retained;
b) 4244 mfd., 4111 dist., 133 retained.

DISTRIBUTION
Nationwide
.

 
Selected Recent Recalls


Health Professional:

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During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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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.