Bulk thyroid drug substance recalled as subpotent from one lot
Specialty Process Labs is recalling one lot of Thyroid, USP bulk drug substance because it is subpotent.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a subpotent thyroid product can result in under-dosing, and no injuries are reported.
Plain-English summary
Thyroid, USP, Rx only, net weight 0.50kg, labelled for manufacturing, processing or repackaging use only, NDC 81305-100-02, is being recalled by Specialty Process Labs LLC of Phoenix, Arizona.
The reason given in the enforcement record is a subpotent drug.
The record lists 58 gms from lot H22254-1XV, expiry 01/31/2027. Distribution was nationwide in the US. The FDA has classified the action as Class II.
A subpotent thyroid product delivers less active substance than labelled. Because the material is labelled for manufacturing, processing or repackaging use only, recipients should follow the firm's instructions and quarantine the affected lot.
The recalled product
- Product
- Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-02
- Manufacturer
- Specialty Process Labs LLC
- Category
- Drug — Bulk drug substance
- Affected units
- 58
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #H22254-1XV
- Exp. 01/31/2027
Distribution
Distributed nationwide across the United States.
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