Risedronate Sodium Tablet, Film Coated
FDA Recall NDC 33342-107
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 Risedronate Sodium (NDC 33342-107). A significant event, classified as Class III, was initiated on Mar 10, 2022 by Macleods Pharmaceuticals Limited. The reported reason for this action was: "FAILED CONTENT UNIFORMITY SPECIFICATIONS"
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 III Terminated
FAILED CONTENT UNIFORMITY SPECIFICATIONS
Mar 10, 2022
Apr 13, 2022
4872 bottles
Recall Profile & Regulatory Data
Event ID
89766
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Macleods Pharma Usa Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Jun 29, 2023
Product Description
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
Affected Packages Involved in this Recall
33342-107-07Product
33342-107-49Product
33342-107-06Product
33342-108-07Product
33342-108-15Product
33342-108-06Product
33342-109-37Product
33342-109-50Product
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.
