FDA Drug recall D-0981-2016
ESTRADIOL CYPIONATE 10 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- FDA Drug
- Class II
- terminated
- Published 2016-06-15
On 2016-06-15 the FDA classified a Class II recall of ESTRADIOL CYPIONATE 10 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121 by Well Care 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-0981-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-17 |
| Published | 2016-06-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Well Care Compounding Pharmacy |
| Distribution | NV |
Product
ESTRADIOL CYPIONATE 10 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Reason
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Identifiers
| code_info | Lot #: 03302016:68@10, Exp.06/28/2016; Lot #: 03082016:83@38, Exp. 06/06/2016; Lot #:02172016:37@51, Exp. 5/17/2016; Lot #: 2102016:80@55, Exp.5/30/2016 |
|---|
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-0981-2016%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.