Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile ...

FDA Drug Recall #D-1606-2014 — Class II — September 8, 2014

Recall Summary

Recall Number D-1606-2014
Classification Class II — Moderate risk
Date Initiated September 8, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Baxter Healthcare Corp
Location Deerfield, IL
Product Type Drugs
Quantity 148632 bags

Product Description

Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile single dose container bags, Rx only, Baxter USA, product code 2B0826, NDC 0338-0709-48.

Reason for Recall

Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.

Distribution Pattern

Nationwide

Lot / Code Information

Lot P318220, EXP 05/31/15

Other Recalls from Baxter Healthcare Corp

Recall # Classification Product Date
D-1131-2015 Class II Heparin Sodium and 0.9% Sodium Chloride Injecti... Jun 3, 2015
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-1542-2014 Class II ProSol - sulfite-free (Amino Acid) Injection, 2... Aug 4, 2014

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.