B Complex Injectable from Talon Compounding Pharmacy Recalled for Sterility Concerns
Talon Compounding Pharmacy is recalling B Complex Injectable (Lot 07192021:91) due to lack of assurance of sterility. The 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 involving a sterility defect in an injectable pharmaceutical product. Lack of sterility assurance in injectable medications presents a serious risk of infection and associated serious injury, meeting the Class II threshold with inherent risk-of-harm to recipients.
Plain-English summary
Vita Pharmacy, LLC, doing business as Talon Compounding Pharmacy, is recalling B Complex Injectable without B12 and without lidocaine (1 vial per unit, Lot 07192021:91, with a beyond-use date of 10/17/2021) due to lack of assurance of sterility.
The recalled injectable was distributed in the United States, including Washington, D.C., and Puerto Rico. This is a prescription-only product that was compounded by the facility located at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247.
Consumers who have this product should not use it. Patients should consult their healthcare provider about appropriate alternatives or replacement therapy. Healthcare providers and patients with questions may contact the recalling firm directly.
The recalled product
- Product
- B COMPLEX INJ CMP-NO B12, NO LIDOCAINE 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
- 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: 07192021:91 BUD: 10/17/2021
Distribution
Distribution scope not specified by the agency.
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