Why it was recalled
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Product description
Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
Lot numbers, UPCs & expiration codes
a) Lot: F3021D, Exp 12/31/2023, Lot: L0722T, Exp 5/31/2025; b) Lot: F1021I, Exp 12/31/2023; c) Lot:H1721R, Exp 12/31/2023, Lot: L0722E, Exp 5/31/2025.
Where it was sold
USA Nationwide
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-0518-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 23, 2023
- FDA report date
- Apr 12, 2023
- Quantity
- a) 266 Bottles, b) not reported, c) 216 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Preferred Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0518-2023, exactly as published.
Show all FDA fields
- City
- Anaheim
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 91952
- Address
- 1250 N Lakeview Ave Ste O
- Code information
- a) Lot: F3021D, Exp 12/31/2023, Lot: L0722T, Exp 5/31/2025; b) Lot: F1021I, Exp 12/31/2023; c) Lot:H1721R, Exp 12/31/2023, Lot: L0722E, Exp 5/31/2025.
- Postal code
- 92807-1801
- Report date
- Apr 12, 2023
- Product type
- Drugs
- Recall number
- D-0518-2023
- Classification
- Class II
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Product quantity
- a) 266 Bottles, b) not reported, c) 216 Bottles
- Reason for recall
- cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 68788-9438-6); c) 90-count bottle (NDC 68788-9438-9), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703.
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Mar 23, 2023
- Initial firm notification
- Letter
- Center classification date
- Apr 6, 2023