Recalls / Class II
Class IID-0923-2023
Product
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
- Brand name
- Tizanidine
- Generic name
- Tizanidine
- Active ingredient
- Tizanidine Hydrochloride
- Route
- Oral
- NDCs
- 55111-179, 55111-180
- FDA application
- ANDA076286
- Affected lot / code info
- Lot: T2100585, T2100586, T2100587, Exp 12/2023
Why it was recalled
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Recalling firm
- Firm
- Dr Reddy's Laboratories Limited
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Notification channel
- N/A
- Type
- N/A
- Address
- Fto-Sez Unit 1, Surv. 57-59,60, 62 & 72, Sect. 9-14, 17-20, Devunipalavalasa, Ranasthalam Mandal, Srikakulam, N/A N/A, India
Distribution
- Quantity
- 17,548 1000-countbottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-06-21
- FDA classified
- 2023-07-17
- Posted by FDA
- 2023-07-26
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0923-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.