Alprostadil 30mcg/ml Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Alprostadil 30mcg/ml injectable due to lack of assurance of sterility. The product was distributed in the United States 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 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 involving a sterile injectable drug where loss of sterility assurance creates serious risk of infection and potential hospitalization. The rubric specifies that FDA Class II recalls with potential for serious patient harm warrant a score of 4.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Alprostadil 30mcg/ml injectable (3 vials per package, Rx only) due to lack of assurance of sterility. The affected product was manufactured by the recalling firm and distributed throughout the United States, including Washington, D.C. and Puerto Rico.
The recall affects three specific lots: Lot 06142021:35 with a beyond-use date of 10/23/2021, Lot 07282021:49 with a beyond-use date of 01/24/2022, and Lot 08302021:48 with a beyond-use date of 02/26/2022.
Patients currently using this product should consult their healthcare provider immediately. Healthcare providers who dispensed this product should contact patients and advise them of the recall. Do not use any remaining supply of the recalled product.
The recalled product
- Product
- ALPROSTADIL 30MCG/ML INJ 30MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Injectable / Compounded
- 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 (3)
- Lot: 06142021:35 BUD: 10/23/2021
- 07282021:49 BUD: 01/24/2022
- 08302021:48 BUD: 02/26/2022
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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