Recalls / Class II
Class IID-0447-2024
Product
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
- Affected lot / code info
- 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.
Why it was recalled
Failed Stability Specifications
Recalling firm
- Firm
- Specialty Process Labs LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1850 E Riverview Dr, Phoenix, Arizona 85034-6703
Distribution
- Quantity
- 217 units
- Distribution pattern
- U.S. Nationwide.
Timeline
- Recall initiated
- 2024-03-01
- FDA classified
- 2024-04-17
- Posted by FDA
- 2024-04-24
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0447-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.