Why it was recalled
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Product description
Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/4 grain (15 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-159-04.
Lot numbers, UPCs & expiration codes
Lot #: 15917VP03, 15917VP02, 15917VP01, Exp 10/31/2019; 15918004, 15918003, 15918002, 15918001, Exp 12/31/2019; 15918VP03, 15918VP02, 15918VP01, 15918005, Exp 2/29/2020; 15918007, 15918006, Exp 3/31/2020.
Where it was sold
Nationwide in the USA 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-1181-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 3, 2018
- FDA report date
- Aug 29, 2018
- Quantity
- Unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Westminster Pharmaceuticals LLC
Original FDA data
Every field from FDA enforcement report D-1181-2018, exactly as published.
Show all FDA fields
- City
- Olive Branch
- State
- MS
- Status
- Terminated
- Country
- United States
- Event ID
- 80719
- Address
- 1 & 2
- Address (line 2)
- 154 Downing Street
- Code information
- Lot #: 15917VP03, 15917VP02, 15917VP01, Exp 10/31/2019; 15918004, 15918003, 15918002, 15918001, Exp 12/31/2019; 15918VP03, 15918VP02, 15918VP01, 15918005, Exp 2/29/2020; 15918007, 15918006, Exp 3/31/2020.
- Postal code
- 38654
- Report date
- Aug 29, 2018
- Product type
- Drugs
- Recall number
- D-1181-2018
- Classification
- Class I
- Recalling firm
- Westminster Pharmaceuticals LLC
- Product quantity
- Unknown
- Termination date
- Jun 3, 2020
- Reason for recall
- Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1/4 grain (15 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-159-04.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Aug 3, 2018
- Initial firm notification
- Letter
- Center classification date
- Sep 7, 2018