D-1344-2014 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 28, 2014
- Initiation Date
- April 22, 2014
- Termination Date
- March 16, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43,007 Bottles
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.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #s: a) 1302201, Exp 01/2015; 1305501, Exp 03/2015; 1314801, Exp 10/2015; b) 1302202, Exp 01/2015