March 2022 FDA Recall Risedronate Sodium by Macleods Pharma Usa Inc
D-0762-2022 - FAILED CONTENT UNIFORMITY SPECIFICATIONS
This Class III drug recall was voluntarily initiated by Macleods Pharma Usa Inc on March 10, 2022 for the product Risedronate Sodium. The FDA reported the reason for recall as failed content uniformity specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0762-2022
FAILED CONTENT UNIFORMITY SPECIFICATIONS
03-10-2022
04-13-2022
4872 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Macleods Pharma Usa 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.
USA Nationwide
06-29-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., BAddi, HImchal Pradesh, INDIA, NDC 33342-107-07.
Batch or Lot Expiration Information
Lot# : BRD2001A, Exp 5/2022
