Liothyronine Sodium Tablet
FDA Recall NDC 42794-019
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Liothyronine Sodium (NDC 42794-019). A significant event, classified as Class II, was initiated on Apr 22, 2014 by Sigmapharm Laboratories, Llc. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
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.
Apr 22, 2014
May 28, 2014
43,007 Bottles
Recall Profile & Regulatory Data
Event ID
68123
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
SigmaPharm Laboratories LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Mar 16, 2015
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.
Batch or Lot Expiration Information
Lot# s: a) 1302201, Exp 01/2015; 1305501, Exp 03/2015; 1314801, Exp 10/2015; b) 1302202, Exp 01/2015
Affected Packages Involved in this Recall
42794-018-02Product
42794-018-12Product
42794-018-06Product
42794-019-02Product
42794-019-06Product
42794-019-12Product
42794-020-02Product
42794-020-12Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
