July 2022 FDA Recall Prednisone by Strides Pharma Inc.
D-1330-2022 - Presence of foreign tablet
This Class II drug recall was voluntarily initiated by Strides Pharma Inc. on July 19, 2022 for the product Prednisone. The FDA reported the reason for recall as presence of foreign tablet. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1330-2022
Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
07-19-2022
08-17-2022
1032 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Strides Pharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide
06-21-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
