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.
Recall initiated: 20171030
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated