The Recall Desk
SevereFDA (Drugs)·D-0131-2022·Announced 2021-11-17

MIC B Complex Injectable Compounded Drug Recall for Sterility Assurance

Talon Compounding Pharmacy is recalling MIC B Complex with Hydroxocobalamin 5MG/ML injectable vials due to lack of assurance of sterility. The recall affects vials distributed across the United States.

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 compounded injectable drug involving lack of sterility assurance. Per the severity rubric, FDA Class II recalls are classified as Severe (score 4) when they involve injectable products where sterility cannot be assured, presenting risk of serious infection.

Plain-English summary

Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling MIC B Complex with Hydroxocobalamin 5MG/ML Injectable due to lack of assurance of sterility. The product is a prescription injectable compounded drug supplied in 6-vial containers.

The affected lot numbers are 07152021:91 (Best Use Date 10/13/2021) and 08202021:06 (Best Use Date 11/18/2021). Distribution includes the United States, Washington, D.C., and Puerto Rico.

Consumers who have received this product should contact their healthcare provider immediately. Patients should not use the recalled vials and should consult with their physician regarding alternative treatment options.

The recall was issued by the FDA as a Class II recall and is identified by recall number D-0131-2022.

The recalled product

Product
MIC B COMPLEX WITH HYDROXOCOBALAMIN 5MG/ML INJ 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
  • sterility-assurance
  • contamination-risk
  • injection-site-infection

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: 07152021:91 BUD: 10/13/2021
  • 08202021:06 BUD: 11/18/2021

Distribution

Distribution scope not specified by the agency.