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December 12, 2000

Synthroid® Tablets Recalled

Mount Olive, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Knoll Pharmaceutical Company is recalling certain Synthroid® tablets because of mis-packaging. 100 mcg product was packaged into 200 mcg card.

This is the first public notice of this Class II recall issued by FDA.

PRODUCT
a) Synthroid® tablets (Levothyroxine sodium tablets, USP) 112 mcg (0.112mg);
b) Synthroid® tablets (Levothyroxine sodium tablets, USP), 200 mcg (0.2mg).

Recall #D-053/054-1.

CODE
a) Lot #00045501, physician samples, 4 cards of 7 tablets;

b) Lot #00045517, physician samples, 4 cards of 7 tablets.
NDC Numbers: 0048-1140 and 0048-1080-96.

MANUFACTURER
Knoll Pharmaceuticals, Jayuya, Puerto Rico.

RECALLED BY
Knoll Pharmaceutical Company, Mount Olive, New Jersey, by E-mail on November 16, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
Undetermined.

QUANTITY
a) 17,476 (boxes of 4 cards); b) 12,998 (boxes of 4 cards) were distributed.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

Notice of this product warning was sent via email to SafetyAlerts subscribers December 12, 2000.  For more information regarding the SafetyAlerts free email alert service please click here.

 
Selected Recent Recalls


Health Professional:

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

How many did you hear about?

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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.