Jubilant Cadista Pharmaceuticals, Inc.: Drug Recall

Recall #D-0096-2023 · 12/27/2022

Class III: Low Risk

Recall Details

Recall Number: D-0096-2023
Classification: Class III
Product Type: Drug
Recalling Firm: Jubilant Cadista Pharmaceuticals, Inc.
Status: Terminated
Date Initiated: 12/27/2022
Location: Salisbury, MD, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 14,061 bottles

Reason for Recall

Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.

Product Description

Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06

Distribution Pattern

Nationwide in the USA.

Other Recalls by Jubilant Cadista Pharmaceuticals, Inc.

Class II: Risk 07/18/2022

Failed Dissolution Specifications
Class II: Risk 07/18/2022

Failed dissolution specifications.
Class III: Low Risk 04/01/2022

Subpotent
Class I: Dangerous 03/08/2022

Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride
Class III: Low Risk 08/20/2021

Subpotent

View all recalls by Jubilant Cadista Pharmaceuticals, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.