Drug product
Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manfuactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, NDC 31722-726-30
D-0081-2019
Product summary
- Event
- Event 80803
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 98016 bottles
- Official record key
drug-enforcement:D-0081-2019
Official wording
Reason: Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
Code information: Lot #: MON17384, Exp 12/19
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-Up