PlainRecalls
FDA Drug Moderate Class II Terminated

Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India

Reported: September 2, 2020 Initiated: August 6, 2020 #D-1545-2020

Product Description

Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India

Reason for Recall

Failed Tablet/Capsule Specification; complaint of bulging tablet

Details

Units Affected
43,512 bottles
Distribution
Product was distributed to major wholesalers/distributors throughout the United States.
Location
Badepalle, N/A

Frequently Asked Questions

What product was recalled?
Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India. Recalled by Hetero Labs Limited (Unit V). Units affected: 43,512 bottles.
Why was this product recalled?
Failed Tablet/Capsule Specification; complaint of bulging tablet
Which agency issued this recall?
This recall was issued by the FDA Drug on September 2, 2020. Severity: Moderate. Recall number: D-1545-2020.