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Recall Observatory FDA recall evidence

Drug product

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

D-1545-2020

August 06, 2020

Class II

Product summary

Firm
Hetero Labs Limited (Unit V)
Event
Event 86191
Status
Terminated
Classification
Class II
Quantity
43,512 bottles
Official record key
drug-enforcement:D-1545-2020

Official wording

Reason: Failed Tablet/Capsule Specification; complaint of bulging tablet

Code information: Batch # LOA19357A, exp. date 09/2021

Distribution pattern: Product was distributed to major wholesalers/distributors throughout the United States.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed Tablet/Capsule Specification; complaint of bulging tablet