Why it was recalled
Failed Stability Specifications
Product description
S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03
Lot numbers, UPCs & expiration codes
Lot #: L13152-1XV, Exp: 11/21/2024; a)1.00 kg, b)0.5 kg, c)100g pack sizes. Lot #: B10383-1XV, Exp: 02/14/2025, a)1 kg, b)0.5 kg, c)100g pack sizes. Lot #: B10453-1X, Exp: 02/15/2025, a)1.00 kg, b)0.5 kg, c)100g pack sizes. Lot #: C10803-1X, Exp: 03/23/2025, a)1.00 kg, c)100g pack sizes. Lot #: E11363-1X, Exp: 05/18/2025, a)1.00 kg, b)0.5 kg, c)100g pack sizes. Lot #: K12753-1X, Exp: 10/12/2025, a)1.00 kg pack sizes. Lot #: L13103-1X, Exp: 11/13/2025, a)1 kg, b)0.5 kg, c)100g pack sizes.
Where it was sold
U.S. Nationwide.
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-0447-2024
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Mar 1, 2024
- FDA report date
- Apr 24, 2024
- Quantity
- 217 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Specialty Process Labs LLC
Original FDA data
Every field from FDA enforcement report D-0447-2024, exactly as published.
Show all FDA fields
- City
- Phoenix
- State
- AZ
- Status
- Completed
- Country
- United States
- Event ID
- 94268
- Address
- 1850 E Riverview Dr
- Code information
- Lot #: L13152-1XV, Exp: 11/21/2024; a)1.00 kg, b)0.5 kg, c)100g pack sizes. Lot #: B10383-1XV, Exp: 02/14/2025, a)1 kg, b)0.5 kg, c)100g pack sizes. Lot #: B10453-1X, Exp: 02/15/2025, a)1.00 kg, b)0.5 kg, c)100g pack sizes. Lot #: C10803-1X, Exp: 03/23/2025, a)1.00 kg, c)100g pack sizes. Lot #: E11363-1X, Exp: 05/18/2025, a)1.00 kg, b)0.5 kg, c)100g pack sizes. Lot #: K12753-1X, Exp: 10/12/2025, a)1.00 kg pack sizes. Lot #: L13103-1X, Exp: 11/13/2025, a)1 kg, b)0.5 kg, c)100g pack sizes.
- Postal code
- 85034-6703
- Report date
- Apr 24, 2024
- Product type
- Drugs
- Recall number
- D-0447-2024
- Classification
- Class II
- Recalling firm
- Specialty Process Labs LLC
- Product quantity
- 217 units
- Reason for recall
- Failed Stability Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC #'s a) 81305-100-01, b)81305-100-02, c)81305-100-03
- Distribution pattern
- U.S. Nationwide.
- Recall initiation date
- Mar 1, 2024
- Initial firm notification
- Letter
- Center classification date
- Apr 17, 2024