FDAFDA · Food and drugs·Recall number D-0823-2020
Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10
Published February 5, 2020 · Recall initiated: January 20, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MONTELUKAST SODIUM
- Manufacturer
- Macleods Pharma Usa Inc
- Distributor
- Nationwide within the United States
- UPC
- 0333342110077
- Lot
- Lot #: BMD8901B, Exp. Date 02/2021
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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