FDA Drug recall D-1568-2015
Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy…
- FDA Drug
- Class II
- terminated
- Published 2015-09-23
On 2015-09-23 the FDA classified a Class II recall of Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy… by The Compounding Pharmacy, citing lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1568-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-02 |
| Published | 2015-09-23 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | The Compounding Pharmacy |
| Distribution | US |
Product
Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Identifiers
| code_info | All lots distributed between November 2014 and May 2015; 04212015@8, 7/20/2015; 03032015@11, 6/1/2015; 03102015@49, 6/…All lots distributed between November 2014 and May 2015; 04212015@8, 7/20/2015; 03032015@11, 6/1/2015; 03102015@49, 6/8/2015; 03192015@9, 6/17/2015; 05042015@14, 8/2/2015; 04072015@20, 7/6/2015; 05042015@51, 8/2/2015 |
|---|
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-1568-2015%22
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