Drug recall
Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario…
FDA recall event 77105 · Class III · The Harvard Drug Group
Key facts
| Event ID | 77105 |
|---|---|
| Recall numbers | D-0692-2017 |
| Recalling firm | The Harvard Drug Group |
| Product type | Drugs |
| Products | Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc., Toronto, Ontario, Canada, Distributed by Major Pharmaceuticals, Livonia, MI NDC 0904-6509-04 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Superpotent Drug; out of specification results for assay (manufacturer) |
| Initiation date | Dec 27, 2016 |
| Report date | May 10, 2017 |
| Termination date | Jul 27, 2017 |
| City | Livonia |
| State | MI |
| Country | United States |
| FEI number | 1818658 |
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: