CLASS II Drug recall · Reported 18 Oct 2017 · FDA Enforcement Report
Glutamine, Arginine and Carnitine, 10/100/200mg/mL (Multi Dose Vial) recalled
United Pharmacy is recalling Glutamine, Arginine and Carnitine, 10/100/200mg/mL (Multi Dose Vial), distributed nationwide in the US. The recall was initiated on 27 Sep 2017 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-0008-2018
- FDA event ID
- 78183
- Recalling firm
- United Pharmacy, West Palm Beach, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Sep 2017
- FDA classified
- 10 Oct 2017
- Reported
- 18 Oct 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 27 Sep 2017 | Recall initiated by company | |
| 10 Oct 2017 | Classified by FDA | +13 days |
| 18 Oct 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Compounded, 13951 N. Haverhill Rd Ste. 120-121 West Palm Beach, FL 33417
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed
Which lots are affected?
Lot: GAC-12 BUD 11/10/17; Lot: GAC-13 BUD: 01/14/18
Where was it sold?
Nationwide.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Glutamine recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Glutamine 10 mg/mL Solution, Pharm D Solutions, Houston, Texas recalled | Pharm D Solutions | Sterility | Nationwide |
| Drug | CLASS II | Glutamine 25 mg/mL. Compounded by Tri-Coast Pharmacy recalled | Tri-Coast Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Glutamine/Arginine/Carnitine 25 mg/100 mg/200 mg/mL recalled | Wells Pharmacy Network | Sterility | Nationwide |
| Drug | CLASS II | Glutamine/Orni/Argin/Lysine/Lido Injectable recalled | Wells Pharmacy Network | Sterility | Nationwide |
| Drug | CLASS II | Glutamine/Orni/Arginine/Lys/Citru+Lido 75 mg/75 mg/150 recalled | Wells Pharmacy Network | Sterility | Nationwide |