The Recall Desk
HighFDA (Drugs)·D-0129-2022·Announced 2021-11-17

MIC B Complex Injectable from Talon Compounding Pharmacy Recalled for Sterility Concerns

Talon Compounding Pharmacy is recalling MIC B Complex INJ-MILES FORMULATION INJECTABLE due to lack of assurance of sterility. The drug is distributed across the United States, including Washington, D.C. and Puerto Rico.

What this means for you

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: This is an FDA Class II recall of a sterile injectable product with a potential for serious harm. The source text does not report any illnesses or injuries, but the hazard—loss of sterility assurance in an injectable—presents a high risk of serious health consequences (infection, sepsis, septic shock) if administered. Per the rubric, high-risk pathogens or risk-of-harm products where injury has not yet been reported score 3.

Plain-English summary

Vita Pharmacy, LLC, doing business as Talon Compounding Pharmacy, located in San Antonio, Texas, is recalling MIC B COMPLEX INJ-MILES FORMULATION INJECTABLE (Rx only) due to lack of assurance of sterility.

The recalled product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. The affected lot is 08112021:46 with a Beyond Use Date (BUD) of 11/09/2021.

Sterility assurance is critical for injectable products because non-sterile injections can introduce bacterial or other microbial contamination directly into the body. Consumers who have received this product should consult their healthcare provider if they have concerns about their treatment or health status.

Anyone with questions about this recall should contact Talon Compounding Pharmacy at the address listed in San Antonio, Texas.

The recalled product

Product
MIC B COMPLEX INJ-MILES FORMULATION 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
  • microbial-contamination
  • 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: 08112021:46 BUD: 11/09/2021

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category