FDA Drug Class III — Least Serious

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

Hazard

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

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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
Brand
Jubilant Cadista Pharmaceuticals, Inc.
UPC
Lot # 17P0430, Exp 05/19

Units Affected

744 bottles

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