FDA Drug Moderate Class II Ongoing

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.

Reported: April 12, 2023 Initiated: March 23, 2023 #D-0518-2023

Product Description

Reason for Recall

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Details

Recalling Firm: Preferred Pharmaceuticals, Inc.
Units Affected: a) 266 Bottles, b) not reported, c) 216 Bottles
Distribution: USA Nationwide
Location: Anaheim, CA

Frequently Asked Questions

What product was recalled? ▼

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.. Recalled by Preferred Pharmaceuticals, Inc.. Units affected: a) 266 Bottles, b) not reported, c) 216 Bottles.

Why was this product recalled? ▼

cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on April 12, 2023. Severity: Moderate. Recall number: D-0518-2023.