Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Ju...
FDA Recall #D-0082-2018 — Class III — October 30, 2017
Product Description
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.
Recalling Firm
Jubilant Cadista Pharmaceuticals, Inc. — Salisbury, MD
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
744 bottles
Distribution
Nationwide
Code Information
Lot # 17P0430, Exp 05/19
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated