0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Braun Medical Inc, 2525...
FDA Drug Recall #D-407-2014 - Class II, November 27, 2013
Recall Summary
| Recall Number | D-407-2014 |
| Classification | Class II - Moderate risk |
| Date Initiated | November 27, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | B. Braun Medical Inc |
| Location | Irvine, CA |
| Product Type | Drugs |
| Quantity | 19,572 bags |
Product Description
0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Braun Medical Inc, 2525 McGaw Ave, Irvine, CA 92614. NDC 0264-7802-00.
Reason for Recall
Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).
Distribution Pattern
Nationwide in the US and Puerto Rico.
Lot / Code Information
Lot No. J3D548, expiry: Oct, 2015
Other Recalls from B. Braun Medical Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0353-2025 | Class II | 0.9% Sodium chloride Irrigation USP, Isotonic S... | Mar 31, 2025 |
| D-0638-2024 | Class I | 0.9% Sodium Chloride Injection USP, E8000, 1000... | Jul 24, 2024 |
| D-0431-2024 | Class II | Lactated Ringer's Injection USP, 1000mL, EXCEL ... | Mar 22, 2024 |
| D-0370-2024 | Class II | Potassium Chloride for Injection Concentrate US... | Mar 6, 2024 |
| D-0579-2023 | Class II | Heparin Sodium, 25,000 USP units per 250mL, (10... | May 9, 2023 |
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.