FDA recall D-0041-2015

Zee Medical Products Inc · Class II · drug

Product

ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC, Manufactured for ZEE Medical Inc., Irvine,CA 92606 by ULTRA Tab Laboratories, Inc. Highland, NY 12528

Reason for recall

Incorrect/Undeclared Excipients: ZEE Medical is recalling ZEE Aspirin due to the incorrect listing of inactive ingredients on the product label.

Distribution

Nationwide in US

Key facts

Status
Terminated
Initiation date
2014-10-07
Report date
2014-10-29
Termination date
2015-04-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0041-2015