FDAFDA · Food and drugs·Recall number D-0081-2019
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
Published October 3, 2018 · Recall initiated: August 15, 2018
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MONTELUKAST SODIUM
- Manufacturer
- Hetero Labs Limited Unit V
- Distributor
- U.S.A. Nationwide
- UPC
- 0331722726306
- Lot
- Lot #: MON17384, Exp 12/19
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- India
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