Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Lt...

FDA Recall #D-0784-2021 — Class III — August 20, 2021

Recall #D-0784-2021 Date: August 20, 2021 Classification: Class III Status: Terminated

Product Description

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

Reason for Recall

Subpotent

Recalling Firm

Jubilant Cadista Pharmaceuticals, Inc. — Salisbury, MD

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

14,544 bottles

Distribution

Product was distributed nationwide.

Code Information

Lot # DN120006A, exp. date 12/2021

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated