FDA Drug recall D-0008-2018
Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Compounded, 13951 N. H…
- FDA Drug
- Class II
- terminated
- Published 2017-10-18
On 2017-10-18 the FDA classified a Class II recall of Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Compounded, 13951 N. H… by United Pharmacy, citing CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0008-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-27 |
| Published | 2017-10-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | United Pharmacy |
| Distribution | US |
Product
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
Reason
CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed
Identifiers
| code_info | Lot: GAC-12 BUD 11/10/17; Lot: GAC-13 BUD: 01/14/18 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0008-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.