FDA recall D-0447-2024

Specialty Process Labs LLC · Class II · drug

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

Reason for recall

Failed Stability Specifications

Distribution

U.S. Nationwide.

Key facts

Status
Completed
Initiation date
2024-03-01
Report date
2024-04-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Phoenix, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0447-2024