Preferred Pharmaceuticals, Inc. recalls Montelukast Sodium Tablets, USP, 10 mg, packaged in: a) 30-count bottle (NDC 68788-9438-3); b) 60-count bottle (NDC 6878
Recalled April 12, 2023 · FDA recall D-0518-2023 · Preferred Pharmaceuticals
Hazard
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. · FDA Class II
Units
a) 266 Bottles, b) not reported, c) 216 Bottles
Sold at
USA Nationwide
Description
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
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.
Manufacturer(s)
Preferred Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →