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Recall Observatory FDA recall evidence

Drug product

Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 and b) 1000-count bottle NDC 42794-018-06, SigmaPharm Laboratories, LLC, Bensalem, Pa.

D-1344-2014

April 22, 2014

Class II

Product summary

Firm
SigmaPharm Laboratories LLC
Event
Event 68123
Status
Terminated
Classification
Class II
Quantity
43,007 Bottles
Official record key
drug-enforcement:D-1344-2014

Official wording

Reason: Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product.

Code information: Lot #s: a) 1302201, Exp 01/2015; 1305501, Exp 03/2015; 1314801, Exp 10/2015; b) 1302202, Exp 01/2015

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product.