FDA recall D-1344-2014

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.

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.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2014-04-22

Report date

2014-05-28

Termination date

2015-03-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bensalem, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1344-2014