Alprostadil Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Alprostadil 22.5mcg/mL Injectable due to lack of assurance of sterility. The affected lot 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 a sterile injectable product with a serious hazard (lack of sterility assurance could result in serious infection). Although no illnesses or injuries are reported in the source text, the hazard is significant and directly applicable to the product's intended use, placing this at the High level per the rubric.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Alprostadil 22.5mcg/mL Injectable, prescription-only medication produced by the company. The recall affects lot 08022021:14 with a beyond-use date of 11/30/2021.
The recall was initiated due to lack of assurance of sterility. Non-sterile injectable products pose a risk of infection when administered to patients.
The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. Patients who have received this medication should consult their healthcare provider. Healthcare providers who dispensed this product should identify affected patients and consider appropriate clinical management.
The recalled product
- Product
- ALPROSTADIL 22.5MCG/ML 22.5MCG/ML 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 / Compounded
- Hazard
- sterility-assurance
- 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: 08022021:14 BUD: 11/30/2021
Distribution
Distribution scope not specified by the agency.
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