Drug recall
Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva…
FDA recall event 71328 · Class II · Valeant Pharmaceuticals North America LLC
Key facts
| Event ID | 71328 |
|---|---|
| Recall numbers | D-1116-2015 |
| Recalling firm | Valeant Pharmaceuticals North America LLC |
| Product type | Drugs |
| Products | Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA 13960. Manufactured in Canada By: Valeant Pharmaceuticals… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point. |
| Initiation date | Apr 17, 2015 |
| Report date | Jun 17, 2015 |
| Termination date | Apr 12, 2016 |
| City | Bridgewater |
| State | NJ |
| Country | United States |
| FEI number | 3010446985 |
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: