Alprostadil Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Alprostadil 40 mcg/mL injectable vials due to lack of assurance of sterility. The recall affects the U.S. including Washington, D.C. and Puerto Rico.
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: The FDA classified this as a Class II recall. The hazard is lack of sterility assurance for an injectable drug, which represents a risk of serious harm (infection, sepsis) to patients if contaminated product were administered. No illnesses or injuries are reported in the source text, but the risk is inherent to the defect.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247, is recalling Alprostadil 40 mcg/mL Injectable (prescription only) due to lack of assurance of sterility.
The recalled product consists of 4 vials distributed throughout the United States, including Washington, D.C. and Puerto Rico. The affected lot numbers and beyond-use dates are: Lot 06242021:37 with BUD 10/22/2021; Lot 08132021:74 with BUD 12/11/2021; and Lot 07132021:94 with BUD 10/23/2021.
Patients currently using this product should consult their healthcare provider or pharmacist immediately. Consumers who have this medication should not use it and should return it to their pharmacy or the recalling firm.
The recalled product
- Product
- ALPROSTADIL 40MCG/ML INJ 40MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Affected units
- 4
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 (3)
- Lot: 06242021:37 BUD: 10/22/2021
- 08132021:74 BUD: 12/11/2021
- 07132021:94 BUD:10/23/2021
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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