Montelukast Sodium Tablets recall: CGMP Deviations
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.
Why was Montelukast Sodium Tablets recalled?
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- 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.
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- Quantity
- a) 266 Bottles, b) not reported, c) 216 Bottles
- Distribution
- USA Nationwide
- Recall date
- April 12, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)