Multi-event March 2024 FDA Recall Drug by Specialty Process Labs Llc
This Multi-event Class II drug recall was voluntarily initiated by Specialty Process Labs Llc on March 1, 2024 for the product Drug. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently completed.
Reported Recall Events
Recall Number: D-0446-2024
Failed Stability Specifications
03-01-2024
04-24-2024
26 units
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Specialty Process Labs LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-500-01.
Batch or Lot Expiration Information
Lot# : H22212-FSV, Exp: 11/21/2024 1.0 kg pack size.
Recall Number: D-0447-2024
Failed Stability Specifications
03-01-2024
04-24-2024
217 units
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Specialty Process Labs LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration 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.
