Potassium Citrate Tablet
FDA Recall NDC 42543-407
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Potassium Citrate (NDC 42543-407). A significant event, classified as Class II, was initiated on Jul 18, 2018 by Strides Pharma Inc.. The reported reason for this action was: "Failed Tablet/Capsule Specifications: Tablet breakage"
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
Failed Tablet/Capsule Specifications: Tablet breakage
Jul 18, 2018
Aug 08, 2018
3,683 bottles
Recall Profile & Regulatory Data
Event ID
80553
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
VENSUN PHARMACEUTICALS INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Within the United States and Puerto Rico.
Termination Date
Apr 16, 2019
Product Description
Potassium Citrate Extended-Release Tablets, USP, 10 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, NDC 42543-407-01.
Batch or Lot Expiration Information
Lot# : 9570012, Exp. June-2019
Affected Packages Involved in this Recall
42543-406-01Product
42543-407-01Product
42543-408-01Product
Class II Terminated
Failed Tablet/Capsule Specifications: Tablet breakage
Jul 18, 2018
Aug 08, 2018
11,652 bottles
Recall Profile & Regulatory Data
Event ID
80553
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
VENSUN PHARMACEUTICALS INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Within the United States and Puerto Rico.
Termination Date
Apr 16, 2019
Product Description
Potassium Citrate Extended-Release Tablets, USP, 15 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, NDC 42543-408-01.
Batch or Lot Expiration Information
Lot# : 9570024, Exp. Jun-2019; 9570027, 9570029, Exp. Jul-2019; 7702088A, 7702089A, Exp. Aug-2019.
Affected Packages Involved in this Recall
42543-406-01Product
42543-407-01Product
42543-408-01Product
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.
