Drug recall
Cyclobenzaprine HCL Tablets, 5 mg, packaged in bottles of 30, Rx only, Packaged by Allscripts, Libertyville…
FDA recall event 50130 · Class II · Allscripts LLC
Key facts
| Event ID | 50130 |
|---|---|
| Recall numbers | D-183-2009, D-184-2009, D-185-2009, D-186-2009, D-187-2009, D-188-2009, D-189-2009, D-190-2009, D-191-2009, D-192-2009, D-193-2009, D-194-2009 |
| Recalling firm | Allscripts LLC |
| Product type | Drugs |
| Products | Cyclobenzaprine HCL Tablets, 5 mg, packaged in bottles of 30, Rx only, Packaged by Allscripts, Libertyville, IL 60045, Manufactured by Actavis Totowa LLC, Totowa, NJ, 07512 USA and Amide…, Hyoscyamine Sulfate Tablets 0.125 mg packaged in blister packs of 20, Rx only, Packaged by Allscripts, Libertyville, IL 60045, Manufactured by Actavis Totowa LLC, Totowa, NJ, 07512 USA and Amide…, Phenazopyridine Tablets, 100 mg, packaged in blister packs of 10, Rx only, Packaged by Allscripts, Libertyville, IL 60045, Manufactured by Actavis Totowa LLC, Totowa, NJ, 07512 USA and Amide…, Phentermine Hydrochloride Capsules, 15 mg, packaged in blister packs of 14 and 28 and bottles of 30 and 60, Schedule IV, Rx only, Packaged by Allscripts, Libertyville, IL 60045, Manufactured by…, Phentermine Hydrochloride Capsules, 37.5 mg, packaged in blister packs of 28 and bottles of 30, Schedule IV, Rx only, Packaged by Allscripts, Libertyville, IL 60045, Manufactured by Actavis Totowa… and 7 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Multiple cGMP deviations and stability failures found at the manufacturer, Actavis Totowa LLC. |
| Initiation date | Jul 1, 2008 |
| Termination date | Nov 4, 2009 |
| City | Libertyville |
| State | IL |
| Country | United States |
| FEI number | 1450743 |
At a glance
- 10–99 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