FDA-Drug2023-04-12Class II
Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c) 30-count bottle (NDC 68788-9868-3), Rx only, Manufactured for: Accord Healthcare, lnc., 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) 88 Bottles, b) 3 Bottles, c) 175 Bottles
Manufactured in
1250 N Lakeview Ave Ste O, Anaheim, CA, United States
Products
Simvastatin Tablets, USP, 40 mg, Packaged as: a) 90-count bottle (NDC 68788-9868-9); b) 60-count bottle (NDC 68788-9868-6); c) 30-count bottle (NDC 68788-9868-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0525-2023Don't want to check this manually?
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