March 14, 2002Prometheus 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).
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 #
a) Lot OZP1108 (300 mg X 100s);
b) Lot 9ZM2082A (300 mg X 100 UD).
Recalling Firm: Prometheus, San Diego, CA, by letter sent February 19, 2002.
Manufacturer: Glaxo Welcome, Zebulon, NC. Firm initiated recall is ongoing.
Dissolution Failure (at stability testing).
VOLUME OF PRODUCT IN COMMERCE
a) 5224 mfd., 5179 dist., 45 retained;
b) 4244 mfd., 4111 dist., 133 retained.