Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd., Bengaluru - 5621
Summary
The FDA issued a Class II for Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strid by Strides Pharma Inc.. Reason: Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets.
Details
Source
Drug Recall
External ID
D-1330-2022
Action Date
2022-08-17
Status
Terminated
Category
drug
Product Description
Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd., Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-785-06.
Lot/Code Info: Lot #: 7248988B, Exp 9/2023
Quantity Affected: 1032 bottles
Reason for Recall
Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
Distribution
US Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-19
Company
East Brunswick, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 41 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Strides Pharma Inc. has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (Strides Pharma Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Strides Pharma Inc. have FDA actions?
Strides Pharma Inc. has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1330-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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