FDA-Drug2017-11-22Class III

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

Jubilant Cadista Pharmaceuticals, Inc.
Hazard

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

Sold states
Nationwide
Affected count
744 bottles
Manufactured in
207 Kiley Dr, N/A, Salisbury, MD, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0082-2018

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