FDA Drug recall D-346-2013
Betamethasone Combination Injection, all strengths and all presentations including a) Beta combo 6 mg/mL, 3 mL, b) Betameth_Combo_PF-6-2 Sy…
- FDA Drug
- Class II
- terminated
- Published 2013-05-22
On 2013-05-22 the FDA classified a Class II recall of Betamethasone Combination Injection, all strengths and all presentations including a) Beta combo 6 mg/mL, 3 mL, b) Betameth_Combo_PF-6-2 Sy… 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-346-2013 |
| 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
Betamethasone Combination Injection, all strengths and all presentations including a) Beta combo 6 mg/mL, 3 mL, b) Betameth_Combo_PF-6-2 Syr, and c) Betamethasone Combo 6 mg/mL Syr, 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 #: a) Beta combo: 20130123-B, Exp 4/23/201, b) Betameth_Combo_PF-6-2 Syr: 13031230GV1, Exp 6/12/2013; 13032060GV2,…Lot #: a) Beta combo: 20130123-B, Exp 4/23/201, b) Betameth_Combo_PF-6-2 Syr: 13031230GV1, Exp 6/12/2013; 13032060GV2, Exp 6/20/2013; 13011650GV7, Exp 4/16/2013; 13012330GV1, Exp 4/23/2013; 13020525Gv1, Exp 5/5/2013; c) Betamethasone Combo 6mg/ml Syr: 20130304-GV2, Exp 5/4/2013; 13031230GV1, Exp 6/12/2013 |
|---|
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-346-2013%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.