Alprostadil Injectable Recalled Due to Lack of Sterility Assurance
Vita Pharmacy, LLC (dba Talon Compounding Pharmacy) is recalling Alprostadil 22 mcg/mL injectable due to lack of assurance of sterility. The affected lot was distributed throughout the United States, including Washington, D.C. and Puerto Rico.
What this means for you
Illness, injury, or structural failure has been reported. 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 compounded injectable drug product lacking sterility assurance. Non-sterile injectables pose a serious risk of infection and patient harm. While no illnesses are reported in the source text, Class II recalls involving loss of sterility for injected products meet the "Severe" threshold under the rubric.
Plain-English summary
Vita Pharmacy, LLC, doing business as Talon Compounding Pharmacy, located in San Antonio, Texas, is recalling Alprostadil 22 mcg/mL injectable (Lot 06082021:61, with a beyond-use date of 10/06/2021) distributed as prescription-only medication. The recall is due to a lack of assurance of sterility for this compounded injectable product.
The affected product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. Patients who received this medication should contact their healthcare provider or pharmacist immediately to determine whether they received the recalled product.
Consumers should not use the recalled medication and should return it to the pharmacy where it was dispensed or to the manufacturer. Healthcare providers and patients should report any adverse events or injuries related to use of this product to the FDA MedWatch program.
The recalled product
- Product
- ALPROSTADIL 22MCG/ML 22MCG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Compounded Injectable
- 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: 06082021:61 BUD: 10/06/2021
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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