Drug recall
ADDERALL XR¿ * (Mixed Salts of A Single Entity Amphetamine Product) * Extended Release Capsules* 20mg*100…
FDA recall event 31258 · Class II · Shire Us Inc
Key facts
| Event ID | 31258 |
|---|---|
| Recall numbers | D-152-5 |
| Recalling firm | Shire Us Inc |
| Product type | Drugs |
| Products | ADDERALL XR¿ * (Mixed Salts of A Single Entity Amphetamine Product) * Extended Release Capsules* 20mg*100 Capsules, Rx only, Shire*Mfg for: Shire US Inc., Newport, KY 41071, Mfg by: DSM… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Mislabeling:Adderall XR 30mg capsules were found within one bottle labeled Adderall XR 20mg capsules. |
| Initiation date | Jan 6, 2005 |
| City | Newport |
| Country | United States |
| FEI number | 3004173607 |
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