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

Recall Number: D-0082-2018

Firm: Jubilant Cadista Pharmaceuticals, Inc.

Classification: Class III

Status: Terminated

Report Date: 20171122

Initiation Date: 20171030

Termination Date: 20200212

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

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