Talon Compounding Pharmacy BCAA Injectable Recalled for Sterility Risk
Vita Pharmacy, LLC (dba Talon Compounding Pharmacy) is recalling BCAA injectable vials 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 classified as FDA Class II, and a lack of sterility assurance in an injectable drug product presents serious risk of infection or other harm to patients who may have already received it. Injectable sterility defects are inherently serious medical hazards.
Plain-English summary
Vita Pharmacy, LLC, doing business as Talon Compounding Pharmacy, is recalling LEUCINE 10MG/ISOLEUCINE 15MG/VALINE 40MG/ML (BCAA) Injectable solution. The product is supplied in 5-vial units and is prescription-only.
The recall was initiated because the manufacturer cannot assure the sterility of the product. Affected lots include Lot 05072021:81 (expiration 11/03/2021) and Lot 08122021:08 (expiration 02/08/2022).
The product was distributed throughout the United States, including Washington D.C. and Puerto Rico. Patients who have received this injectable should consult their healthcare provider immediately. The pharmacy is the recalling firm located at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247.
The recalled product
- Product
- LEUCINE 10MG/ ISOLEUCINE 15MG/ VALINE 40MG/ML (BCAA) INJ 10MG/15MG/40MG/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-failure
- injectable-contamination-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 (2)
- Lot: 05072021:81 BUD: 11/03/2021
- 08122021:08 BUD: 02/08/2022
Distribution
Distribution scope not specified by the agency.
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