Drug recall
Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured…
FDA recall event 79969 · Class II · Exela Pharma Sciences LLC
Key facts
| Event ID | 79969 |
|---|---|
| Recall numbers | D-0826-2018 |
| Recalling firm | Exela Pharma Sciences LLC |
| Product type | Drugs |
| Products | Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India; For: EAGLE PHARMACEUTICALS, INC., Woodcliff Lake, NJ 07677 USA… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets. |
| Initiation date | Apr 20, 2018 |
| Report date | May 30, 2018 |
| Termination date | Jun 4, 2020 |
| City | Lenoir |
| State | NC |
| Country | United States |
| FEI number | 3008563008 |
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: