Home / Recalls / Jubilant Cadista Pharmaceuticals, Inc. / D-1205-2018

D-1205-2018 Class III Terminated

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

Recall Details

Product Type
Drugs
Report Date
September 26, 2018
Initiation Date
August 27, 2018
Termination Date
October 8, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
89,722 blister pack

Product Description

MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03

Reason for Recall

Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.

Distribution Pattern

Product was distributed throughout the United States.

Code Information

Lot # 17P0078, exp. date 12/2018

Other recalls by Jubilant Cadista Pharmaceuticals, Inc.

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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)