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Class III · Lower riskRecall completed

Potassium Chloride

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot #: 7238958A, 7238257A, Exp 7/31/2021; 7239404A, Exp 9/30/2021
Where it was soldU.S.A. Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byStrides Shasun Limited Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816 foreign manufacturer
Brand namePOTASSIUM CHLORIDE
Generic namePOTASSIUM CHLORIDE
Active ingredient(s)POTASSIUM CHLORIDE
Distributed by / forStrides Pharma Inc., East Brunswick, NJ 08816
NDC64380-861-08
Show the full FDA record
Full product labelPotassium 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
Recalling firmStrides Pharma Science Limited
DistributionU.S.A. Nationwide
Quantity2576 bottles
Recall initiated2020-02-17
Report date2020-03-25
Recall completed2021-02-16
Recall numberD-1029-2020
ClassificationClass III
FDA statusTerminated
Origin on fileBangalore India

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.