Home / Recalls / Jubilant Cadista Pharmaceuticals, Inc. / D-0576-2020

D-0576-2020 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
December 18, 2019
Initiation Date
December 2, 2019
Termination Date
October 14, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,824 bottles

Product Description

Amantadine Hydrochloride Tablets, 100 mg, 100-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA; NDC 59746-699-01.

Reason for Recall

Presence of Foreign Substance: Presence of a foreign object in a single tablet.

Distribution Pattern

Nationwide in the USA.

Code Information

Lot #: NT119005A, Exp 07/2021

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  • 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)