FDA-Drug2023-04-12Class II
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.
Preferred Pharmaceuticals, Inc.
Hazard
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Sold states
USA Nationwide
Affected count
a) 266 Bottles, b) not reported, c) 216 Bottles
Manufactured in
1250 N Lakeview Ave Ste O, Anaheim, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0518-2023Don't want to check this manually?
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