Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Mary
Summary
The FDA issued a Class III for Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadist by Jubilant Cadista Pharmaceuticals, Inc.. Reason: Subpotent Drug: Out of specification for assay at the 18-month stability timepoint..
Details
Source
Drug Recall
External ID
D-0096-2023
Action Date
2023-01-11
Status
Terminated
Category
drug
Product Description
Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06
Lot/Code Info: Lot#: 21P0336, Exp: 04/2023
Quantity Affected: 14,061 bottles
Reason for Recall
Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-27
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 22 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-0096-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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