November 2017 FDA Recall Valsartan by Prinston Pharmaceutical Inc
D-0209-2018 - Failed Tablet/Capsule Specifications
This Class II drug recall was voluntarily initiated by Prinston Pharmaceutical Inc on November 29, 2017 for the product Valsartan. 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-0209-2018
Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
11-29-2017
01-17-2018
21,987 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Prinston Pharmaceutical Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA and Puerto Rico
08-16-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare US, LLC, Cranbury, NJ 08512, USA; NDC 43547-369-09.
Batch or Lot Expiration Information
Lot# : 343B17025, Exp 03/31/19
