FDA Drug recall D-1432-2015
5-Methy Tetrahydrofolate 5 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN
- FDA Drug
- Class II
- terminated
- Published 2015-09-23
On 2015-09-23 the FDA classified a Class II recall of 5-Methy Tetrahydrofolate 5 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN 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-1432-2015 |
| 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
5-Methy Tetrahydrofolate 5 mg/ml Injectable, Sterile-Multi-Dose Vial, 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; 02232015@75, 5/24/2015; 03042015@22, 6/2/2015; 03172015@44,…All lots distributed between November 2014 and May 2015; 02232015@75, 5/24/2015; 03042015@22, 6/2/2015; 03172015@44, 6/15/2015; 03192015@21, 6/17/2015; 03232015@61, 6/21/2015; 03272015@49, 6/25/2015; 04132015@50, 7/12/2015; 04132015@54, 7/12/201; 04152015@35, 7/14/2015; 04162015@12, 7/15/2015; 04222015@39, 7/21/2015, 04242015@3, 7/23/2015; 05012015@53, 7/30/2015; 05062015@20, 8/4/2015; 05052015@105, 8/3/2015 |
|---|
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-1432-2015%22
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