Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by:
Summary
The FDA issued a Class III for Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jub by Jubilant Cadista Pharmaceuticals, Inc.. Reason: Subpotent.
Details
Source
Drug Recall
External ID
D-0784-2021
Action Date
2021-09-08
Status
Terminated
Category
drug
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
Lot/Code Info: Lot # DN120006A, exp. date 12/2021
Quantity Affected: 14,544 bottles
Reason for Recall
Subpotent
Distribution
Product was distributed nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-20
Company
Salisbury, MD
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 40 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Jubilant Cadista Pharmaceuticals, Inc. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Jubilant Cadista Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Jubilant Cadista Pharmaceuticals, Inc. have FDA actions?
Jubilant Cadista Pharmaceuticals, Inc. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0784-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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