FDA Drug recall D-0518-2023
Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3)
- FDA Drug
- Class II
- ongoing
- Published 2023-04-12
On 2023-04-12 the FDA classified a Class II recall of Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3) by Preferred Pharmaceuticals, citing cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0518-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-23 |
| Published | 2023-04-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Preferred Pharmaceuticals |
| Distribution | US |
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.
Reason
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Identifiers
| code_info | 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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0518-2023%22
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