Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Pl...

FDA Drug Recall #D-1131-2015 — Class II — June 3, 2015

Recall Summary

Recall Number D-1131-2015
Classification Class II — Moderate risk
Date Initiated June 3, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Baxter Healthcare Corp
Location Deerfield, IL
Product Type Drugs
Quantity 145,350 containers

Product Description

Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- NDC 0338-0431-03

Reason for Recall

Subpotent Drug; out of specification results for heparin raw material

Distribution Pattern

Nationwide

Lot / Code Information

Product Code: 280953 Lots: N002998 and N003004 exp 12/31/15; and lot N003038 exp. 01/31/2016

Other Recalls from Baxter Healthcare Corp

Recall # Classification Product Date
D-0429-2015 Class II 0.9% Sodium Chloride Injection, USP, 50 mL, VIA... Mar 23, 2015
D-0428-2015 Class II Clinimix E 5/20 sulfite-free (5% amino-acid wit... Mar 23, 2015
D-481-2015 Class I 0.9% Sodium Chloride Injection USP, 100 mL MINI... Dec 4, 2014
D-1606-2014 Class II Potassium Chloride Injection, 10 mEq per 100 mL... Sep 8, 2014
D-1542-2014 Class II ProSol - sulfite-free (Amino Acid) Injection, 2... Aug 4, 2014

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.