PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: May 28, 2014 Initiated: April 22, 2014 #D-1344-2014

Product Description

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.

Reason for Recall

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.

Details

Units Affected
43,007 Bottles
Distribution
Nationwide and Puerto Rico
Location
Bensalem, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by SigmaPharm Laboratories LLC. Units affected: 43,007 Bottles.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 28, 2014. Severity: Moderate. Recall number: D-1344-2014.