March 2016 FDA Recall Drug by Biocon Inc
D-0817-2016 - Subpotent Drug

This Class III drug recall was voluntarily initiated by Biocon Inc on March 24, 2016 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed in PA, CA, & OH and the recall is currently terminated.

Recall Number: D-0817-2016

Reason for Recall
Subpotent Drug
Initiated
03-24-2016
Reported
04-20-2016
Quantity
5505 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73699
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Biocon Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
PA, CA, & OH
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-04-2017
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# 14S0042F5B, exp. 4/2016