July 2018 FDA Recall Drug by H J Harkins Company Inc Dba Pharma Pac
D-1022-2018 - Carcinogen impurity detected in API used to manufacture drug product.

This Class II drug recall was voluntarily initiated by H J Harkins Company Inc Dba Pharma Pac on July 26, 2018 for the product Drug. The FDA reported the reason for recall as carcinogen impurity detected in api used to manufacture drug product.. The product was distributed in Product was distributed to a physician's office. and the recall is currently terminated.

Recall Number: D-1022-2018

Reason for Recall
Carcinogen impurity detected in API used to manufacture drug product.
Initiated
07-26-2018
Reported
08-08-2018
Quantity
540 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80674
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.
H J Harkins Company Inc dba Pharma Pac
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.
Product was distributed to a physician's office.
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 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 43547-0369-09. Tablet is yellow, capsule-shaped, biconvex, film-coated tablets debossed with 343 on one side and HH on the other side.

Batch or Lot Expiration Information

Lot# VSA000OV Manufacturer's original
Lot# 343B17015, exp date 02/19 NDC 43547-0369-09