Drug recall
Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC…
FDA recall event 77060 · Class II · Fagron, Inc
Key facts
| Event ID | 77060 |
|---|---|
| Recall numbers | D-0791-2017, D-0792-2017 |
| Recalling firm | Fagron, Inc |
| Product type | Drugs |
| Products | Estriol, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-1392-1), b) 5 G bottle (NDC: 51552-1392-2), c) 25 G bottle (NDC: 51552-1392-3), d) 100 G bottle (NDC: 51552-1392-5), RX…, Estrone, For Prescription Compounding, packaged in a) 1 G bottle (NDC: 51552-0445-1), b) 5 G bottle (NDC 51552-0445-2), c) 25 G bottle (NDC: 51552-0445-4), d) 100 G bottle (NDC: 51552-0445-5), RX… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | cGMP Deviations: lack of quality assurance at the API manufacturer. |
| Initiation date | Apr 6, 2017 |
| Report date | May 31, 2017 |
| Termination date | Jul 1, 2019 |
| City | Saint Paul |
| State | MN |
| Country | United States |
| FEI number | 1000174332 |
At a glance
- 1–9 Products in this recall
- 10–99 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: