Drug 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.
Lots and codes
Lot #: MON17355, Exp 12/19
Recall details
- Recalling firm
- Hetero Labs Limited Unit V, Jadcherla Mandal, Mahaboob Nagar
- Quantity
- 98,016 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 20, 2018
- Terminated
- November 5, 2021
Related products
- Montelukast Sodium – drug information
- NDC 31722-726 Montelukast Sodium · Montelukast Sodium 10 mg/1 · Camber Pharmaceuticals, Inc.