May 2014 FDA Recall Fluvastatin by Teva Pharmaceuticals Usa
D-1430-2014 - Failed Tablet/Capsule Specifications

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on May 29, 2014 for the product Fluvastatin. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1430-2014

Reason for Recall
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.
Initiated
05-29-2014
Reported
07-16-2014
Quantity
8,472 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68441
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA
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.
Nationwide and Guam, Puerto Rico, American Samoa, Virgin Islands
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-09-2015
Product Description About Product Description
Full technical description of the product.
Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD, Jerusalem, Israel, NDC 0093-7442-56

Batch or Lot Expiration Information

Lot# : F47008, Exp. 7/2015

Affected Packages Involved in this Recall

0093-7442-56 Fluvastatin
0093-7442-01 Fluvastatin
0093-7443-56 Fluvastatin
0093-7443-01 Fluvastatin