CLASS II ONGOING Drug recall · Reported 20 Jul 2022 · FDA Enforcement Report
GAC (Glutamine/Arginine/L-Carnitine) recalled by TMC Acquisition
TMC Acquisition is recalling GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL-vial, Refrigerate, Tailor Made, distributed nationwide in the US. The recall was initiated on 7 Mar 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1203-2022
- FDA event ID
- 89909
- Recalling firm
- TMC Acquisition, Nicholasville, KY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Mar 2022
- FDA classified
- 14 Jul 2022
- Reported
- 20 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 7 Mar 2022 | Recall initiated by company | |
| 14 Jul 2022 | Classified by FDA | +129 days |
| 20 Jul 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
Where it was distributed
Nationwide USA and Puerto Rico
Questions about this recall
Is GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL-vial, Refrigerate, Tailor Made recalled?
Yes. TMC Acquisition recalled GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL-vial, Refrigerate, Tailor Made on 7 Mar 2022. The recall is Class II and its status is Ongoing. Recall number D-1203-2022.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Batch #: 10122110A2, Exp 3/20/2022; 12062110A2, Exp 4/30/2022; 02012202A2, 02192207A1, Exp 7/31/2022.
Where was it sold?
Nationwide USA and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from TMC Acquisition
All 52| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Methylene Blue Hypotonic Solution, 10mg/mL, a)-vial recalled | TMC Acquisition | Sterility | Nationwide |
| Drug | CLASS II | Testosterone Cypionate/Enanthate 100/100mg/ml, a)-vial recalled | TMC Acquisition | Sterility | Nationwide |
| Drug | CLASS II | Sermorelin/Glycine 2000mcg/5mg/mL-vial, Refrigerate recalled | TMC Acquisition | Sterility | Nationwide |
| Drug | CLASS II | Biotin 5mg/mL-vial, Refrigerate, Tailor Made Compounding recalled | TMC Acquisition | Sterility | Nationwide |
| Drug | CLASS II | Hydroxocobalamin Preservative Free 5mg/mL-vial, Refrigerate recalled | TMC Acquisition | Sterility | Nationwide |