Progesterone Injectable Recalled Due to Lack of Sterility Assurance
Talon Compounding Pharmacy is recalling Progesterone 100mg/mL Injectable because the manufacturer cannot assure the product meets sterility requirements. The recall affects one vial distributed across the United States.
What this means for you
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 an FDA Class II recall of a sterile injectable drug. The source text does not report any illnesses or injuries, so the hazard is theoretical; however, lack of sterility assurance in an injectable product creates a direct risk of serious infection. The score is 3 per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Progesterone 100mg/mL Injectable in Ethyl Oleate (Lot 07192021:31, BUD 10/17/2021) due to lack of assurance of sterility. Injectable medications must be sterile to prevent potentially serious infections.
The recalled product is a prescription injection distributed to healthcare facilities and pharmacies throughout the United States, including Washington, D.C. and Puerto Rico. The recall affects 1 vial of the product.
Patients who have received this injection should contact their healthcare provider. Healthcare providers and pharmacies that received this product should stop using it and return it to the manufacturer.
The recalled product
- Product
- PROGESTERONE 100MG/ML INJ #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Manufacturer
- Vita Pharmacy, LLC dba Talon Compounding Pharmacy
- Category
- Drug — Injectable Pharmaceutical
- Hazard
- sterility-failure
- infection-risk
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 (1)
- Lot: 07192021:31 BUD: 10/17/2021
Distribution
Distribution scope not specified by the agency.
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