Drug recall
Zanaflex Capsules, tizanidine hydrochloride, 2 mg, bottles of 150 capsules, Rx only, Marketed by: Acorda…
FDA recall event 58049 · Class II · Acorda Therapeutics Inc.
Key facts
| Event ID | 58049 |
|---|---|
| Recall numbers | D-415-2011, D-416-2011 |
| Recalling firm | Acorda Therapeutics Inc. |
| Product type | Drugs |
| Products | Zanaflex Capsules, tizanidine hydrochloride, 2 mg, bottles of 150 capsules, Rx only, Marketed by: Acorda Therapeutics, Inc., Hawthorne, NY NDC/UPC Code 10144-602-15, Zanaflex Capsules, tizanidine hydrochloride, 4 mg, bottles of 150 capsules, Rx only, Marketed by: Acorda Therapeutics, Inc., Hawthorne, NY --- NDC/UPC Code 10144-604-15 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Subpotent; empty capsules were found in certain lots |
| Initiation date | Mar 1, 2011 |
| Termination date | Aug 2, 2012 |
| City | Hawthorne |
| State | NY |
| Country | United States |
| FEI number | 3002457563 |
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