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.
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-0525-2023More Preferred Pharmaceuticals, Inc. recalls
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