FDA recall D-1213-2018

Product

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

Reason for recall

Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-08-20

Report date

2018-10-03

Termination date

2021-11-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Jadcherla Mandal, Mahaboob Nagar, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1213-2018