FDA recall D-0082-2018

Product

Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06

Reason for recall

Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-10-30

Report date

2017-11-22

Termination date

2020-02-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salisbury, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0082-2018