Drug recall
EMBEDA (morphine sulfate and naltrexone hydrochloride), 100 mg/4 mg, Extended Release Capsules, 100 count…
FDA recall event 55214 · Class III · King Pharmaceuticals Inc
Key facts
| Event ID | 55214 |
|---|---|
| Recall numbers | D-581-2010, D-582-2010, D-583-2010, D-584-2010, D-585-2010, D-586-2010 |
| Recalling firm | King Pharmaceuticals Inc |
| Product type | Drugs |
| Products | EMBEDA (morphine sulfate and naltrexone hydrochloride), 100 mg/4 mg, Extended Release Capsules, 100 count bottle, Rx only; Manufactured for King Pharmaceuticals, Inc., Bristol, TN 37620; Manufactured…, EMBEDA (morphine sulfate and naltrexone hydrochloride, 20 mg/0.8 mg), Extended Release Capsules, 100 count bottle, Rx only; Manufactured for King Pharmaceuticals, Inc., Bristol, TN 37620; Manufactured…, EMBEDA (morphine sulfate and naltrexone hydrochloride, 30 mg/1.2 mg), Extended Release Capsules, 100 count bottle, Rx only; Manufactured for King Pharmaceuticals, Inc., Bristol, TN 37620; Manufactured…, EMBEDA (morphine sulfate and naltrexone hydrochloride), 50 mg/2.0 mg, Extended Release Capsules, 100 count bottle, Rx only; Manufactured for King Pharmaceuticals, Inc., Bristol, TN 37620; Manufactured…, EMBEDA (morphine sulfate and naltrexone hydrochloride, 60 mg/2.4 mg), Extended Release Capsules, 100 count bottle, Rx only; Manufactured for King Pharmaceuticals, Inc., Bristol, TN 37620; Manufactured… and 1 more |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed dissolution testing for Morphine Sulfate during stability testing. |
| Initiation date | Mar 23, 2010 |
| Termination date | Jan 10, 2011 |
| City | Bristol |
| State | TN |
| Country | United States |
| FEI number | 1000208638 |
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