February 2020 FDA Recall Potassium Chloride by Strides Pharma Science Limited
D-1029-2020 - Failed Tablet/Capsules Specifications

This Class III drug recall was voluntarily initiated by Strides Pharma Science Limited on February 17, 2020 for the product Potassium Chloride. The FDA reported the reason for recall as failed tablet/capsules specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1029-2020

Reason for Recall
Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.
Initiated
02-17-2020
Reported
03-25-2020
Quantity
2576 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84968
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Strides Pharma Science Limited
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-16-2021
Product Description About Product Description
Full technical description of the product.
Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-861-08

Batch or Lot Expiration Information

Lot# : 7238958A, 7238257A, Exp 7/31/2021; 7239404A, Exp 9/30/2021

Affected Packages Involved in this Recall

64380-860-06 Potassium Chloride
64380-860-07 Potassium Chloride
64380-860-08 Potassium Chloride
64380-861-06 Potassium Chloride
64380-861-07 Potassium Chloride
64380-861-08 Potassium Chloride