August 2021 FDA Recall Drug by Jubilant Cadista Pharmaceuticals, Inc.
D-0784-2021 - Subpotent

This Class III drug recall was voluntarily initiated by Jubilant Cadista Pharmaceuticals, Inc. on August 20, 2021 for the product Drug. The FDA reported the reason for recall as subpotent. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0784-2021

Reason for Recall
Subpotent
Initiated
08-20-2021
Reported
09-08-2021
Quantity
14,544 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88523
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Jubilant Cadista Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-05-2022
Product Description About Product Description
Full technical description of the product.
Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801 NDC 59746-329-90

Batch or Lot Expiration Information

Lot# DN120006A, exp. date 12/2021