FDA Drug recall D-399-2013
Phosphatidylcholine and Sodium Deoxycholate Injection, all strengths and all presentations including Phospha_Deoxy-35-30-50 mL, Rx only, Gr…
- FDA Drug
- Class II
- terminated
- Published 2013-05-22
On 2013-05-22 the FDA classified a Class II recall of Phosphatidylcholine and Sodium Deoxycholate Injection, all strengths and all presentations including Phospha_Deoxy-35-30-50 mL, Rx only, Gr… by Fvs Holdings Dba Green Valley Drugs, citing lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associate….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-399-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-10 |
| Published | 2013-05-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fvs Holdings Dba Green Valley Drugs |
| Distribution | US |
Product
Phosphatidylcholine and Sodium Deoxycholate Injection, all strengths and all presentations including Phospha_Deoxy-35-30-50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Reason
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes..
Identifiers
| code_info | Lot #: 201303071500JN, Exp 6/7/2013; 1301231000AE, Exp 4/23/2013 |
|---|
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-399-2013%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.