Recall: D-1213-2018

Class II - Potentially Harmful

Class IIClassification

2018-08-20Initiated

TerminatedStatus

Hetero Labs Limited Unit VFirm

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

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.