FDA Drug recall D-1616-2015
Nandrolone Decanoate 200 mg/ml Injection, ml Multi-Dose Vial, Sterile, Room Temperature, 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 Nandrolone Decanoate 200 mg/ml Injection, ml Multi-Dose Vial, Sterile, Room Temperature, 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-1616-2015 |
| 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
Nandrolone Decanoate 200 mg/ml Injection, ml 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: 02272015@1, 8/26/2015; 12182015@67, 6/16/2015; 02062015@141…All lots distributed between November 2014 and May 2015: 02272015@1, 8/26/2015; 12182015@67, 6/16/2015; 02062015@141, 8/5/2015; 04222015@13, 9/29/2015; 04072015@33, 10/4/2015; 04212015@13, 10/18/2015; 04082015@7, 10/5/2015 ; 04142015@24, 10/11/2015; 04272015@84, 10/24/2015; and 05082015@7, 11/4/2015 |
|---|
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-1616-2015%22
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