Drug recall
Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators)…
FDA recall event 84071 · Class II · Glenmark Pharmaceuticals Inc., USA
Key facts
| Event ID | 84071 |
|---|---|
| Recall numbers | D-0156-2020 |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA |
| Product type | Drugs |
| Products | Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-71) and b) 18-count Vaginal Inserts (with disposable applicators)… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator. |
| Initiation date | Oct 22, 2019 |
| Report date | Nov 6, 2019 |
| Termination date | Jun 7, 2021 |
| City | Mahwah |
| State | NJ |
| Country | United States |
| FEI number | 3005658103 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: