December 12, 2000Synthroid® Tablets Recalled
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.
a) Synthroid® tablets (Levothyroxine sodium tablets, USP) 112 mcg (0.112mg);
b) Synthroid® tablets (Levothyroxine sodium tablets, USP), 200 mcg (0.2mg).
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.
Knoll Pharmaceuticals, Jayuya, Puerto Rico.
Knoll Pharmaceutical Company, Mount Olive, New Jersey, by E-mail on November 16, 2000.
Firm-initiated recall ongoing.
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.
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