The Recall Desk
HighFDA (Drugs)·D-0116-2022·Announced 2021-11-17

Talon Compounding Pharmacy Injectable Amino Acid Solution Recall

Talon Compounding Pharmacy is recalling GOAL-GLUTAMINE injectable solution due to lack of assurance of sterility. The affected product was distributed across the United States.

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 drug product. Lack of sterility assurance in injectable medications poses a significant risk of infection and harm to patients; however, the source text does not report any confirmed illnesses or injuries, keeping the score at 3 rather than 4.

Plain-English summary

Talon Compounding Pharmacy is recalling GOAL-GLUTAMINE 75MG/ORNITHINE 75MG/ARGININE 150MG/LYSINE 150MG + LIDOCAINE 10MG/ML injectable solution. The recall affects 5 vials with lot numbers 05062021:44 (BUD 11/02/2021) and 08192021:87 (BUD 02/15/2022).

The product is being recalled due to lack of assurance of sterility. This is a prescription-only injectable medication manufactured by Vita Pharmacy, LLC dba Talon Compounding Pharmacy, located at 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247.

The affected product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. Consumers who have received this product should contact their healthcare provider immediately.

The recalled product

Product
GOAL-GLUTAMINE 75MG/ORNITHINE 75MG/ARGININE 150MG/LYSINE 150MG+LIDOCAINE 10MG/ML 75MG/75MG/150MG/150MG/10MG/ML 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
  • injection-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 (2)

  • Lot: 05062021:44 BUD: 11/02/2021
  • 08192021:87 BUD: 02/15/2022

Distribution

Distribution scope not specified by the agency.