D-0518-2023 Class II Ongoing
FDA drug recall D-0518-2023 was initiated by Preferred Pharmaceuticals, Inc. on March 23, 2023 and is designated Class II. Reason for recall: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. The recall status is ongoing. Affected quantity: a) 266 Bottles, b) not reported, c) 216 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 12, 2023
- Initiation Date
- March 23, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 266 Bottles, b) not reported, c) 216 Bottles
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.
Reason for Recall
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Distribution Pattern
USA Nationwide
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.