Thyroid pharmaceutical ingredient recalled for failed stability specifications
Specialty Process Labs is recalling S.P.Labs Thyroid, Full Strength (NDC 81305-500-01) due to failed stability specifications. The ingredient was distributed nationwide for pharmaceutical manufacturing use.
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: This is a pharmaceutical ingredient with documented failed stability specifications, constituting a risk-of-harm product where injury has not yet been reported. The FDA Class II classification and lack of reported illnesses or injuries place it at the High severity level per the rubric.
Plain-English summary
Specialty Process Labs LLC is recalling S.P.Labs Thyroid, Full Strength (NDC 81305-500-01, Lot #H22212-FSV) due to failed stability specifications. This is an active pharmaceutical ingredient intended for manufacturing, processing, or repackaging use by pharmaceutical companies, not for direct consumer use.
The recalled lot was distributed nationwide in 1.0 kg pack sizes (26 units total) with an expiration date of November 2024. Pharmaceutical manufacturers and repackagers who received this ingredient should discontinue use and contact Specialty Process Labs for return or disposal instructions.
The recalled product
- 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.
- Manufacturer
- Specialty Process Labs LLC
- Category
- Drug — Pharmaceutical Ingredient
- Hazard
- Affected units
- 26
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 #: H22212-FSV
- Exp: 11/21/2024 1.0 kg pack size.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Specialty Process Labs LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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- Moderate
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