Alprostadil 45mcg/mL Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Alprostadil 45mcg/mL injectable due to lack of assurance of sterility. The affected product was distributed across the United States, 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 injectable pharmaceutical product. Lack of sterility assurance in injectable medications poses risk of serious infection and hospitalization; this meets the Class II with risk-of-serious-injury criterion for a Severe rating.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Alprostadil 45mcg/mL injectable (Lot: 06112021:61, BUD: 10/09/2021) because the firm cannot assure the product meets sterility requirements. The recall affects 2 vials of this prescription injectable medication.
The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. Patients currently using this medication should consult their healthcare provider or pharmacist about the recall and obtain a replacement from their pharmacy or healthcare provider.
The recalled product
- Product
- ALPROSTADIL 45MCG/ML 45MCG/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
- Hazard
- lack-of-sterility
- contamination-risk
- 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: 06112021:61 BUD: 10/09/2021
Distribution
Distribution scope not specified by the agency.
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