Recalls / Class III
Class IIID-0823-2020
Product
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
- Brand name
- Montelukast Sodium
- Generic name
- Montelukast Sodium
- Active ingredient
- Montelukast
- Route
- Oral
- NDCs
- 33342-110, 33342-111
- FDA application
- ANDA203582
- Affected lot / code info
- Lot #: BMD8901B, Exp. Date 02/2021
Why it was recalled
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Recalling firm
- Firm
- Macleods Pharma Usa Inc
- Manufacturer
- Macleods Pharmaceuticals Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230, N/A, Plainsboro, New Jersey 08536-0009
Distribution
- Quantity
- 10680 units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-01-20
- FDA classified
- 2020-01-31
- Posted by FDA
- 2020-02-05
- Terminated
- 2021-04-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0823-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.