FDA recall D-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

Reason for recall

Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2023-06-21

Report date

2023-07-26

Voluntary/Mandated

N/A

Location

Ranasthalam Mandal, Srikakulam, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0923-2023