Why it was recalled
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
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
Lot numbers, UPCs & expiration codes
Lot #: BMD8901B, Exp. Date 02/2021
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0823-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 20, 2020
- FDA report date
- Feb 5, 2020
- Quantity
- 10680 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Macleods Pharma Usa Inc
Original FDA data
Every field from FDA enforcement report D-0823-2020, exactly as published.
Show all FDA fields
- City
- Plainsboro
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84749
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230
- Code information
- Lot #: BMD8901B, Exp. Date 02/2021
- Postal code
- 08536-0009
- Report date
- Feb 5, 2020
- Product type
- Drugs
- Recall number
- D-0823-2020
- Classification
- Class III
- Recalling firm
- Macleods Pharma Usa Inc
- Product quantity
- 10680 units
- Termination date
- Apr 26, 2021
- Reason for recall
- Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jan 20, 2020
- Initial firm notification
- Letter
- Center classification date
- Jan 31, 2020