Home / Recalls / Jubilant Cadista Pharmaceuticals, Inc. / D-0082-2018

D-0082-2018 Class III Terminated

Recalled by Jubilant Cadista Pharmaceuticals, Inc. — Salisbury, MD

Recall Details

Product Type: Drugs
Report Date: November 22, 2017
Initiation Date: October 30, 2017
Termination Date: February 12, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 744 bottles

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.

Distribution Pattern

Nationwide

Code Information

Lot # 17P0430, Exp 05/19

Other recalls by Jubilant Cadista Pharmaceuticals, Inc.

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D-1293-2022 Class II — Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jub (July 18, 2022)
D-0752-2022 Class III — Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: (April 1, 2022)
D-0767-2022 Class I — Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles ( (March 8, 2022)
D-0784-2021 Class III — Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jub (August 20, 2021)
D-0333-2021 Class II — Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubil (April 1, 2021)
D-0298-2021 Class III — Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx on (February 19, 2021)
D-0104-2021 Class II — clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufa (November 6, 2020)
D-0066-2021 Class III — Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) bliste (October 26, 2020)