Drug Enforcement D-0447-2024

Failed Stability Specifications

Status

Ongoing

Classification

Class II

Report Date

April 24, 2024

Termination Date

Product Information

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
Product quantity
217 units
Reason for recall
Failed Stability Specifications
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
U.S. Nationwide.

Location & Firm

Recalling firm
Specialty Process Labs LLC
Address
1850 E Riverview Dr

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0447-2024
Event ID
94268
Recall initiation date
March 1, 2024
Center classification date
April 17, 2024
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.
More code info