Drug recall
Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA…
FDA recall event 78652 · Class II · ALLERGAN
Key facts
| Event ID | 78652 |
|---|---|
| Recall numbers | D-0154-2018 |
| Recalling firm | ALLERGAN |
| Product type | Drugs |
| Products | Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine, CA 92612, Manufactured in Canada, NDC 58914-117-10 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile. |
| Initiation date | Dec 4, 2017 |
| Report date | Jan 17, 2018 |
| Termination date | Jun 20, 2019 |
| City | Madison |
| State | NJ |
| Country | United States |
| FEI number | 3013696134 |
At a glance
- 1–9 Products in this recall
- None 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: