Hetero Labs Limited Unit V recalls Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadc
Recalled October 3, 2018 · FDA recall D-1213-2018 · Hetero Labs Limited Unit V
Hazard
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets. · FDA Class II
Units
98,016 bottles
Sold at
Nationwide in the USA
Description
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
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.
Manufacturer(s)
Hetero Labs Limited Unit V
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →