Prednisone Tablet
FDA Recall NDC 64380-784
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Prednisone (NDC 64380-784). A significant event, classified as Class II, was initiated on Jul 19, 2022 by Strides Pharma Science Limited. The reported reason for this action was: "Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
Jul 19, 2022
Aug 17, 2022
1032 bottles
Recall Profile & Regulatory Data
Event ID
90634
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Strides Pharma Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide
Termination Date
Jun 21, 2023
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.
Batch or Lot Expiration Information
Lot# : 7248988B, Exp 9/2023
Affected Packages Involved in this Recall
64380-784-01Product
64380-784-07Product
64380-784-08Product
64380-784-06Product
64380-785-06Product
64380-785-07Product
64380-785-08Product
64380-785-01Product
64380-949-06Product
64380-949-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
