The Recall Desk
SevereFDA (Drugs)·D-0121-2022·Announced 2021-11-17

Talon Compounding Pharmacy IVME SUPER B Injectable Recalled for Sterility Assurance

Talon Compounding Pharmacy is recalling IVME SUPER B 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: The FDA has classified this as a Class II recall. Lack of sterility assurance in an injectable product poses risk of serious infection or adverse health consequences, meeting the threshold for Severe (score 4) per the rubric criterion for FDA Class II recalls.

Plain-English summary

Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247, is recalling IVME SUPER B Injectable due to lack of assurance of sterility.

The affected product consists of 99 vials with the following lot numbers and beyond-use dates: Lot 07262021:54 (BUD 10/24/2021), Lot 07262021:04 (BUD 10/24/2021), Lot 09092021:07 (BUD 12/09/2021), Lot 09092021:97 (BUD 12/09/2021), and Lot 09102021:10 (BUD 12/09/2021).

The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. This is a prescription-only injectable medication. Patients who have received doses of this product should consult their healthcare provider immediately. Healthcare providers should review patient records to identify potentially affected recipients.

The recalled product

Product
IVME SUPER B 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
Category
Drug — Injectable / Compounded Pharmacy
Hazard
  • sterility-failure
  • infection-risk
  • injectable-safety

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 (5)

  • Lot: 07262021:54 BUD: 10/24/2021
  • 07262021:04 BUD: 10/24/2021
  • 09092021:07 BUD: 12/09/2021
  • 09092021:97 BUD: 12/09/2021
  • 09102021:10 BUD: 12/09/2021

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category