Triova Recalls Estriol USP Micronized 5 G Due to Impurities
Triova Pharmaceuticals is recalling Estriol USP Micronized 5 G because the product failed specifications for organic impurities.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is a quality specification failure rather than a high-risk pathogen or structural defect.
Plain-English summary
Triova Pharmaceuticals LLC is recalling Estriol USP Micronized 5 G, a prescription-only medication. The recall is due to the product failing impurities and degradation specifications, specifically being out of specification for organic impurities.
The affected product is identified by NDC 71092-9977-02. The recall includes lots with expiration dates of 12/2020. The product was distributed nationwide in the United States.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa, OK 74103, NDC 71092-9977-02
- Manufacturer
- TRIOVA PHARMACEUTICALS LLC
- Category
- Drug — Prescription Medication
- Hazard
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 (4)
- Lot #:17010401181119190927
- EXP 12/2020
- 1701040118111919092725200122
- EXP.12/2020
Distribution
Distributed nationwide across the United States.
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