Alprostadil Injectable Recall: Lack of Sterility Assurance
Talon Compounding Pharmacy is recalling Alprostadil 25 mcg/mL injectable vials distributed across the United States due to lack of assurance of sterility, which could pose a health risk to patients.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a sterile injectable drug with a fundamental sterility assurance failure. Class II recalls can cause serious health consequences, and injectable products that lack sterility assurance pose a risk of serious infection or other significant adverse outcomes when administered to patients.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Alprostadil 25 mcg/mL Injectable (Rx only) due to lack of assurance of sterility. The affected product consists of 3 vials with lot numbers 04232021:91 (BUD 10/20/2021) and 08022021:76 (BUD 11/30/2021).
The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. Injectable medications require strict sterility standards to prevent serious infections and complications when administered to patients.
Patients who have received this product or healthcare providers with this medication in stock should stop use and consult with a healthcare professional regarding their treatment options and any potential exposure.
The recalled product
- Product
- ALPROSTADIL 25MCG/ML 25MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Affected units
- 3
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 (2)
- Lot: 04232021:91 BUD: 10/20/2021
- 08022021:76 BUD: 11/30/2021
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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