Recalls / Class II
Class IID-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.
- Brand name
- Liothyronine Sodium
- Generic name
- Liothyronine Sodium
- Active ingredient
- Liothyronine Sodium
- Route
- Oral
- NDCs
- 42794-018, 42794-019, 42794-020
- FDA application
- ANDA200295
- Affected lot / code info
- Lot #s: a) 1302201, Exp 01/2015; 1305501, Exp 03/2015; 1314801, Exp 10/2015; b) 1302202, Exp 01/2015
Why it was 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.
Recalling firm
- Firm
- SigmaPharm Laboratories LLC
- Manufacturer
- SIGMAPHARM LABORATORIES, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3375 Progress Dr, N/A, Bensalem, Pennsylvania 19020-5801
Distribution
- Quantity
- 43,007 Bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-04-22
- FDA classified
- 2014-05-21
- Posted by FDA
- 2014-05-28
- Terminated
- 2015-03-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1344-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.