ESTRADIOL VALERATE 10MG/ML — Class II drug recall D-0982-2016
Terminated recall by Well Care Compounding Pharmacy, reported 2016-06-15, distributed in NV. Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality
| Recall number | D-0982-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Well Care Compounding Pharmacy, Las Vegas, NV, United States |
| Recall initiated | 2016-05-17 |
| Classified | 2016-06-09 |
| Reported by FDA | 2016-06-15 |
| Terminated | 2017-01-13 |
| Distributed | NV |
| Quantity | 869 units |
| Reason classes | sterility, cgmp |
| Expiration dates | 2016-05-03, 2016-06-12, 2016-06-15, 2016-07-11, 2016-07-20 |
Product
ESTRADIOL VALERATE 10MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Reason for recall
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
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-0982-2016. 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.