Drug recall
Kaletra capsules (Lopinavir/Ritonavir), Each soft gelatin capsule contains: Lopinavir 133.3mg, Ritonavir…
FDA recall event 27094 · Class II · Harvard Drug Group, The
Key facts
| Event ID | 27094 |
|---|---|
| Recall numbers | D-013-4 |
| Recalling firm | Harvard Drug Group, The |
| Product type | Drugs |
| Products | Kaletra capsules (Lopinavir/Ritonavir), Each soft gelatin capsule contains: Lopinavir 133.3mg, Ritonavir 33.3mg, 180 capsule bottles, Rx only, Abbott Laboratories, North Chicago, IL 60064 NDC… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Counterfeit; bottles labeled as containing Kaletra capsules may contain Kaletra capsules and/or Agenerase capsules or a mix of both, as well as, bottles of Kaletra capsules have been… |
| Initiation date | Aug 19, 2003 |
| City | Livonia |
| 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