The Recall Desk
SevereFDA (Drugs)·D-0146-2022·Announced 2021-11-17

Talon Compounding Pharmacy Injectable Lacks Sterility Assurance

Talon Compounding Pharmacy is recalling TRIMTROPIC injectable due to lack of assurance of sterility. The affected lot 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: The FDA classified this as a Class II recall. Lack of sterility assurance in an injectable product poses significant risk of infection and other serious complications, meeting the criteria for a Severe rating when combined with the Class II classification.

Plain-English summary

Vita Pharmacy, LLC, doing business as Talon Compounding Pharmacy, is recalling TRIMTROPIC - MIC B COMPLEX/CHROM/CARN 20MG/40MG/50MG/5MG/33MG/2MG/1MG/25MCG/25MG Injectable (Rx only) due to lack of assurance of sterility.

The recalled product is a 1 vial injectable formulation manufactured by Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247. The affected lot is 08062021:92 with a beyond-use date of 02/02/2022.

The product was distributed across the United States, including Washington, D.C., and Puerto Rico. Patients who have received this product should consult their healthcare provider if they have any concerns.

The recalled product

Product
TRIMTROPIC - MIC B COMPLEX/CHROM/CARN 20MG/40MG/50MG/5MG/33MG/2MG/1MG/25MCG/25MG 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

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: 08062021:92 BUD: 02/02/2022

Distribution

Distribution scope not specified by the agency.