Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharm...

FDA Drug Recall #D-0209-2018 — Class II — November 29, 2017

Recall Summary

Recall Number D-0209-2018
Classification Class II — Moderate risk
Date Initiated November 29, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Prinston Pharmaceutical Inc
Location Cranbury, NJ
Product Type Drugs
Quantity 21,987 bottles

Product Description

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.

Reason for Recall

Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.

Distribution Pattern

Nationwide in the USA and Puerto Rico

Lot / Code Information

Lot #: 343B17025, Exp 03/31/19

Other Recalls from Prinston Pharmaceutical Inc

Recall # Classification Product Date
D-0412-2019 Class II Irbesartan and Hydrochlorothiazide Tablets, USP... Jan 18, 2019
D-0413-2019 Class II Irbesartan and Hydrochlorothiazide Tablets, USP... Jan 18, 2019
D-0411-2019 Class II Irbesartan and Hydrochlorothiazide Tablets, USP... Jan 18, 2019
D-0410-2019 Class II Irbesartan and HydrochlorothiazideTablets, USP ... Jan 18, 2019
D-0409-2019 Class II Irbesartan Tablets 300 mg 90 count Rx only ... Jan 18, 2019

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.