Home / Recalls / Jubilant Cadista Pharmaceuticals, Inc. / D-0333-2021

D-0333-2021 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
April 21, 2021
Initiation Date
April 1, 2021
Termination Date
April 28, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Lot #IT119008B - (4,128 Bottles); Lot #IT20001A - (3,984 Bottles); Lot #IT20002B - (4.080 Bottles)

Product Description

Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-282-30.

Reason for Recall

Failed Dissolution Specifications

Distribution Pattern

Nationwide in the USA

Code Information

Lot #s: IT119008B, Exp 05/2021; IT120001A, IT120002A, Exp 12/2021

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-1293-2022 Class II — Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jub (July 18, 2022)
  • D-1294-2022 Class II — Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubi (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-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)
  • D-1281-2020 Class III — Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: (May 26, 2020)