Glutamine — Class II drug recall D-0008-2018
Terminated recall by United Pharmacy, reported 2017-10-18, distributed nationwide. CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impuriti
| Recall number | D-0008-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | United Pharmacy, West Palm Beach, FL, United States |
| Recall initiated | 2017-09-27 |
| Classified | 2017-10-10 |
| Reported by FDA | 2017-10-18 |
| Terminated | 2018-03-29 |
| Distributed | Nationwide (US) |
| Quantity | 268 vials |
| Reason classes | cgmp, specification failure |
| Lot numbers | GAC-12, GAC-13 |
| Expiration dates | 2017-11-10, 2018-01-14 |
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 for recall
CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0008-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.