Alprostadil injectable recalled due to lack of sterility assurance
Vita Pharmacy LLC (dba Talon Compounding Pharmacy) is recalling Alprostadil 32 mcg/mL injectable due to lack of assurance of sterility. The product was distributed across the United States, including Washington D.C. and Puerto Rico.
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 an injectable drug with a sterility defect that poses significant risk of serious harm (infection) if administered. Although no illnesses are reported in the source text, the hazard is inherent to non-sterile injectable products and meets the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Vita Pharmacy LLC, operating as Talon Compounding Pharmacy, is recalling Alprostadil 32 mcg/mL injectable (Lot 08262021:68, BUD 12/24/2021) distributed throughout the United States, including Washington D.C. and Puerto Rico.
The recall is due to lack of assurance of sterility. Alprostadil is a prescription injectable medication, and non-sterile injectable products pose a risk of serious infection if administered to patients.
Patients currently using this medication should contact their healthcare provider immediately to discuss alternative treatment options. Healthcare providers who received this product should quarantine remaining inventory and verify that no doses have been administered to patients.
The recalled product
- Product
- ALPROSTADIL 32MCG/ML 32MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Injectable / Compounded
- Affected units
- 1
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: 08262021:68 BUD: 12/24/2021
Distribution
Part of a larger recall action
This product is one of 130 recalled by Vita Pharmacy, LLC dba Talon Compounding Pharmacy 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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