Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only...

FDA Drug Recall #D-0256-2015 — Class II — November 10, 2014

Recall Summary

Recall Number D-0256-2015
Classification Class II — Moderate risk
Date Initiated November 10, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Baxter Healthcare Corp.
Location Deerfield, IL
Product Type Drugs
Quantity 63,360 container bags

Product Description

Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-0709-48, Product Code 2B0826.

Reason for Recall

Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.

Distribution Pattern

Nationwide

Lot / Code Information

Lot #: P319160, Exp 06/30/15

Other Recalls from Baxter Healthcare Corp.

Recall # Classification Product Date
D-0852-2016 Class II Brevibloc DOUBLE STRENGTH Premixed Injection, E... Apr 12, 2016
D-0731-201 Class II 0.9% Sodium Chloride Irrigation, USP, 500 mL bo... Feb 5, 2016
D-0862-2016 Class I 0.9% Sodium Chloride Injection USP, MINI-BAG Pl... Jan 21, 2016
D-0861-2016 Class II 0.9% Sodium Chloride Injection USP, MINI-BAG Pl... Jan 21, 2016
D-0863-2016 Class I Metronidazole Injection USP, 500 mg per 100 mL ... Jan 21, 2016

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced 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.