Class I
Ongoing
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
- Company
- Hetero Labs Limited Unit V
- Recall Initiated
- August 15, 2018
- Posted
- October 3, 2018
- Recall Number
- D-0081-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 98016 bottles
- Firm Location
- Jadcherla Mandal, Mahaboob Nagar, India
Reason for Recall
Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
Distribution
U.S.A. Nationwide
Lot / Code Info
Lot #: MON17384, Exp 12/19
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