Home / Recalls / Jubilant Cadista Pharmaceuticals, Inc. / D-1058-2020

D-1058-2020 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
March 25, 2020
Initiation Date
March 11, 2020
Termination Date
June 10, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
89,376 90-count bottles

Product Description

Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx Only, Manufactured by Jubilant Generics Ltd, Roorkee-247661 India, NDC 59746-284-90

Reason for Recall

CGMP Deviations: Presence of dark brown discoloration on edges of tablets

Distribution Pattern

Distributed Nationwide in the USA

Code Information

Lot # PA218005A, exp. date 12/2020, PA218P010, PA218P011, exp. date 04/2021, PA218108A, PA218110A, exp. date 06/2021

Other recalls by Jubilant Cadista Pharmaceuticals, Inc.

  • D-0096-2023 Class III — Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadist (December 27, 2022)
  • D-1294-2022 Class II — Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubi (July 18, 2022)
  • 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)