August 2020 FDA Recall Drug by Hetero Labs Limited (unit V) (D-1545-2020 - Failed Tablet/Capsule Specification; complaint of bulging tablet)

This Class II drug recall was voluntarily initiated by Hetero Labs Limited (unit V) on August 6, 2020 for the product Drug. The FDA reported the reason for recall as failed tablet/capsule specification; complaint of bulging tablet. The product was distributed in Product was distributed to major wholesalers/distributors throughout the United States. and the recall is currently terminated.

Recall Number: D-1545-2020

Reason for Recall
Failed Tablet/Capsule Specification; complaint of bulging tablet
Initiated
08-06-2020
Reported
09-02-2020
Quantity
43,512 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86191
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Hetero Labs Limited (Unit V)
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.
Product was distributed to major wholesalers/distributors throughout the United States.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-24-2022
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Batch# LOA19357A, exp. date 09/2021