IC B Complex Injectable Recalled for Lack of Sterility Assurance
Talon Compounding Pharmacy is recalling IC B Complex Injectable due to lack of assurance of sterility. The affected vial lot 09152021:12 was distributed across the United States, 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a compounded injectable pharmaceutical product with loss of sterility assurance, which is a high-risk hazard for injection-route drugs. The source states FDA Class II classification. Although no illnesses or injuries are explicitly reported in the source, the potential for serious harm (infection, sepsis) from non-sterile injectables meets the criteria for a High severity rating.
Plain-English summary
Vita Pharmacy, LLC, doing business as Talon Compounding Pharmacy, is recalling IC B Complex Injectable (Rx only) due to lack of assurance of sterility. The product is a compounded injectable solution distributed in single vials.
The recalled product was lot 09152021:12 with a beyond-use date of 12/14/2021, distributed throughout the United States, including Washington, D.C., and Puerto Rico. The compounding pharmacy is located at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247.
Consumers and healthcare providers should not use this product. Persons who may have received this medication should contact their healthcare provider or pharmacist for guidance. The lack of sterility assurance in injectable products presents a potential health risk, as sterile conditions are critical for injectables to prevent infection and other complications.
The recalled product
- Product
- IC B COMPLEX INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- 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: 09152021:12 BUD: 12/14/2021
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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