FDA-Drug2016-04-20Class III

Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 count (NDC 24658-0300-10 )bottles, Manufactured by: Blu Caribe Dorado PR 00646, Manufactured for: Blu Pharmaceuticals Franklin, KY 42134

Biocon Inc
Hazard

Subpotent Drug

Sold states
PA, CA, & OH
Affected count
5505 bottles
Manufactured in
485 US Highway 1 S Ste B305, N/A, Iselin, NJ, United States
Products
Simvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 count (NDC 24658-0300-10 )bottles, Manufactured by: Blu Caribe Dorado PR 00646, Manufactured for: Blu Pharmaceuticals Franklin, KY 42134

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0817-2016

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