FDA recall D-0894-2023

Preferred Pharmaceuticals, Inc. · Class II · drug

Product

Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-count bottles, (NDC: 68788-7781-6), d) 90-count bottles (NDC: 68788-7781-9), e) 120-count bottles (NDC: 68788-7781-8), Rx only, Mfg: Dr. Reddy's Laboratories Limited.

Reason for recall

Failed Stability Specifications

Distribution

Nationwide within the United States

Key facts

Status: Ongoing
Initiation date: 2023-06-26
Report date: 2023-07-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Anaheim, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0894-2023