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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Category
- Drug — Injectable / Compounded
- Affected units
- 5
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
Part of a larger recall action
This product is one of 130 recalled by Vita Pharmacy, LLC dba Talon Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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