Drug recall
Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited…
FDA recall event 92564 · Class II · Dr Reddy's Laboratories Limited
Key facts
| Event ID | 92564 |
|---|---|
| Recall numbers | D-0923-2023 |
| Recalling firm | Dr Reddy's Laboratories Limited |
| Product type | Drugs |
| Products | Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed dissolution specification: Out of specification results observed in 24-month long term stability testing. |
| Initiation date | Jun 21, 2023 |
| Report date | Jul 26, 2023 |
| City | Ranasthalam Mandal, Srikakulam |
| Country | India |
| FEI number | 3009193040 |
At a glance
- 1–9 Products in this recall
- 1–9 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 · Source date: