S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix,
Summary
The FDA issued a Class II for S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Us by Specialty Process Labs LLC. Reason: Failed Stability Specifications.
Details
Source
Drug Recall
External ID
D-0447-2024
Action Date
2024-04-24
Status
Completed
Category
drug
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/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.
Quantity Affected: 217 units
Reason for Recall
Failed Stability Specifications
Distribution
U.S. Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-01
Company
Phoenix, AZ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 26 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Specialty Process Labs LLC has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Specialty Process Labs LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Specialty Process Labs LLC have FDA actions?
Specialty Process Labs LLC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0447-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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