Why it was recalled
Failed Dissolution Specifications.
Product description
Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perrigo Minneapolis, MN 55427, NDC 0574-0222-01
Lot numbers, UPCs & expiration codes
Lot: #:16F649, Exp: May 2018
Where it was sold
Nationwide within USA
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-0098-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 9, 2017
- FDA report date
- Dec 6, 2017
- Quantity
- 11,364 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mayne Pharma Inc
Original FDA data
Every field from FDA enforcement report D-0098-2018, exactly as published.
Show all FDA fields
- City
- Greenville
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 78544
- Address
- 1240 Sugg Pkwy
- Code information
- Lot: #:16F649, Exp: May 2018
- Postal code
- 27834-9006
- Report date
- Dec 6, 2017
- Product type
- Drugs
- Recall number
- D-0098-2018
- Classification
- Class II
- Recalling firm
- Mayne Pharma Inc
- Product quantity
- 11,364 bottles
- Termination date
- May 11, 2020
- Reason for recall
- Failed Dissolution Specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perrigo Minneapolis, MN 55427, NDC 0574-0222-01
- Distribution pattern
- Nationwide within USA
- Recall initiation date
- Nov 9, 2017
- Initial firm notification
- Letter
- Center classification date
- Nov 29, 2017