FDA recall D-1230-2015

Product

Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-11); 5 blister packs per carton (NDC 68084-008-65); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

Reason for recall

CGMP Deviations: Firm did not adequately investigate customer complaints.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-06-01

Report date

2015-07-15

Termination date

2017-02-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1230-2015