Multi-event July 2018 FDA Recall Potassium Citrate by Vensun Pharmaceuticals Inc
This Multi-event Class II drug recall was voluntarily initiated by Vensun Pharmaceuticals Inc on July 18, 2018 for the product Potassium Citrate. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed in Within the United States and Puerto Rico. and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1018-2018
Failed Tablet/Capsule Specifications: Tablet breakage
07-18-2018
08-08-2018
3,683 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.
VENSUN PHARMACEUTICALS 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.
Within the United States and Puerto Rico.
04-16-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-1017-2018
Failed Tablet/Capsule Specifications: Tablet breakage
07-18-2018
08-08-2018
11,652 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.
VENSUN PHARMACEUTICALS 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.
Within the United States and Puerto Rico.
04-16-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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.
