FDA-Drug2020-09-02Class II

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

Hetero Labs Limited (Unit V)
Hazard

Failed Tablet/Capsule Specification; complaint of bulging tablet

Sold states
Product was distributed to major wholesalers/distributors throughout the United States.
Affected count
43,512 bottles
Manufactured in
458 Surv No 439 - 441, Polepally Village, Badepalle, N/A, India
Products
Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1545-2020

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