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.
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.
Lot numbers, UPCs & expiration codes
Lot #s: a) 1302201, Exp 01/2015; 1305501, Exp 03/2015; 1314801, Exp 10/2015; b) 1302202, Exp 01/2015
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1344-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 22, 2014
- FDA report date
- May 28, 2014
- Quantity
- 43,007 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SigmaPharm Laboratories LLC
Original FDA data
Every field from FDA enforcement report D-1344-2014, exactly as published.
Show all FDA fields
- City
- Bensalem
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 68123
- Address
- 3375 Progress Dr
- Code information
- Lot #s: a) 1302201, Exp 01/2015; 1305501, Exp 03/2015; 1314801, Exp 10/2015; b) 1302202, Exp 01/2015
- Postal code
- 19020-5801
- Report date
- May 28, 2014
- Product type
- Drugs
- Recall number
- D-1344-2014
- Classification
- Class II
- Recalling firm
- SigmaPharm Laboratories LLC
- Product quantity
- 43,007 Bottles
- Termination date
- Mar 16, 2015
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Apr 22, 2014
- Initial firm notification
- Letter
- Center classification date
- May 21, 2014