March 2019 FDA Recall Drug by American Health Packaging
D-1047-2019 - CGMP Deviation

This Class II drug recall was voluntarily initiated by American Health Packaging on March 6, 2019 for the product Drug. The FDA reported the reason for recall as cgmp deviation. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1047-2019

Reason for Recall
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Initiated
03-06-2019
Reported
03-27-2019
Quantity
3337 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82316
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.
American Health Packaging
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 USA and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-09-2020
Product Description About Product Description
Full technical description of the product.
Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 (Individual Dose NDC:60687-139-11, Carton NDC#: 60687-139-01)

Batch or Lot Expiration Information

Lot# Lot 179791, Mar 2020