D-0817-2016 Class III Terminated

Recalled by Biocon Inc — Iselin, NJ

Recall Details

Product Type
Drugs
Report Date
April 20, 2016
Initiation Date
March 24, 2016
Termination Date
December 4, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5505 bottles

Product Description

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

Reason for Recall

Subpotent Drug

Distribution Pattern

PA, CA, & OH

Code Information

Lot # 14S0042F5B, exp. 4/2016