August 2018 FDA Recall Drug by Preferred Pharmaceuticals, Inc
D-1107-2018 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Preferred Pharmaceuticals, Inc on August 15, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Products were distributed to one distributor in Alabama who may have further distributed the product to the consumer level. and the recall is currently terminated.

Recall Number: D-1107-2018

Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Initiated
08-15-2018
Reported
08-29-2018
Quantity
9 bottles consisting of 90 tables each bottle

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80840
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.
Preferred Pharmaceuticals, 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.
Products were distributed to one distributor in Alabama who may have further distributed the product to the consumer level.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-18-2019
Product Description About Product Description
Full technical description of the product.
Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx Only, Preferred Pharmaceuticals, Inc., 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807, NDC 68788-6882-9

Batch or Lot Expiration Information

Lot# G2017F NDC 68788-6882-9