Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc. S
Summary
The FDA issued a Class III for Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: by Jubilant Cadista Pharmaceuticals, Inc.. Reason: Subpotent.
Details
Source
Drug Recall
External ID
D-0752-2022
Action Date
2022-04-13
Status
Terminated
Category
drug
Product Description
Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-001-06
Lot/Code Info: Lot # 21 P0322, Exp. 01/2023
Quantity Affected: 19,222 Bottles (100-count)
Reason for Recall
Subpotent
Distribution
Nationwide in the USA and Puerto Rico
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-01
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 47 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-0752-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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