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
Reported: February 5, 2020 Initiated: January 20, 2020 #D-0823-2020
Product Description
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
Reason for Recall
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Details
- Recalling Firm
- Macleods Pharma Usa Inc
- Units Affected
- 10680 units
- Distribution
- Nationwide within the United States
- Location
- Plainsboro, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Macleods Pharma Usa Inc. Units affected: 10680 units.
Why was this product recalled? ▼
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 5, 2020. Severity: Low. Recall number: D-0823-2020.
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