Status
Ongoing
Drug Enforcement D-0923-2023
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
Classification
Class II
Report Date
July 26, 2023
Termination Date
—
Product Information
- Product description
- 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
- Product quantity
- 17,548 1000-countbottles
- Reason for recall
- Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
- Recall initiation reason
- —
- Initial firm notification
- N/A
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Dr Reddy's Laboratories Limited
- Address
-
Fto-Sez Unit 1, Surv. 57-59,60, 62 & 72, Sect. 9-14, 17-20, Devunipalavalasa
India - Voluntary / Mandated
- N/A
- Status date
- —
Codes & Dates
- Recall number
- D-0923-2023
- Event ID
- 92564
- Recall initiation date
- June 21, 2023
- Center classification date
- July 17, 2023
- Code info
- Lot: T2100585, T2100586, T2100587, Exp 12/2023
- More code info
- —