Drug recall
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC…
FDA recall event 76282 · Class III · Sun Pharmaceutical Industries, Inc.
Key facts
| Event ID | 76282 |
|---|---|
| Recall numbers | D-0445-2017, D-0446-2017 |
| Recalling firm | Sun Pharmaceutical Industries, Inc. |
| Product type | Drugs |
| Products | buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88) and c) 500 (NDC 47335-737-13) count bottles, Rx only, Distributed by: Sun…, buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Dissolution Specifications; 18 month stability time point |
| Initiation date | Dec 20, 2016 |
| Report date | Feb 1, 2017 |
| Termination date | Jul 11, 2018 |
| City | Cranbury |
| State | NJ |
| Country | United States |
| FEI number | 3005551493 |
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: