FDA recall D-0081-2019

Product

Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, NDC 31722-726-30

Reason for recall

Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.

Distribution

U.S.A. Nationwide

Key facts

Status

Ongoing

Initiation date

2018-08-15

Report date

2018-10-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Jadcherla Mandal, Mahaboob Nagar, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0081-2019