Estradiol Valerate Injection — Class II drug recall D-365-2013
Terminated recall by FVS Holdings, Inc. dba. Green Valley Drugs, reported 2013-05-22, distributed nationwide. Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compoundi
| Recall number | D-365-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | FVS Holdings, Inc. dba. Green Valley Drugs, Henderson, NV, United States |
| Recall initiated | 2013-04-10 |
| Classified | 2013-05-16 |
| Reported by FDA | 2013-05-22 |
| Terminated | 2014-03-21 |
| Distributed | Nationwide (US) |
| Quantity | 243 vials |
| Reason classes | sterility |
| Lot numbers | 20130114-B |
| Expiration dates | 2013-04-14 |
Product
Estradiol Valerate Injection, all strengths and all presentations including a) Estradiol Valerate 40-10 mL and b) Estradiol Valerate 40-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-365-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.