Drug 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.
D-1213-2018
Product summary
- Event
- Event 81029
- Status
- Terminated
- Classification
- Class II
- Quantity
- 98,016 bottles
- Official record key
drug-enforcement:D-1213-2018
Official wording
Reason: Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Code information: Lot #: MON17355, Exp 12/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.