0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc....
FDA Drug Recall #D-0346-2023 — Class II — February 10, 2023
Recall Summary
| Recall Number | D-0346-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 10, 2023 |
| Status | Completed |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | B. Braun Medical Inc. |
| Location | Daytona Beach, FL |
| Product Type | Drugs |
| Quantity | 1,343,982 bags |
Product Description
0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
Reason for Recall
Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.
Distribution Pattern
USA Nationwide.
Lot / Code Information
Lots: 0061786962 Exp. 11/30/2023; 0061797767 Exp. 04/30/2024; 0061797768 Exp. 05/31/2024; 0061787769 Exp. 05/31/2024; 0061797770 Exp. 05/31/2024; 0061797771 Exp. 05/31/2024; 0061797772 Exp. 05/31/2024; 0061797773 Exp. 05/31/2024; 0061797774 Exp. 05/31/2024; 0061797775 Exp. 05/31/2024; 0061797776 Exp. 05/31/2024; 0061812946 Exp. 05/31/2024; 0061812947 Exp. 05/31/2024; 0061812948 Exp. 05/31/2024; 0061812949 Exp. 05/31/2024; 0061812950 Exp. 05/31/2024; 0061816017 Exp. 06/30/2024; 0061816018 Exp. 06/30/2024; 0061816019 Exp. 06/30/2024; 0061816020 Exp. 06/30/2024; 0061816021 Exp. 06/30/2024; 0061816358 Exp. 06/30/2024; 0061816359 Exp. 06/30/2024; 0061816361 Exp. 07/31/2024; 0061816362 Exp. 07/31/2024; 0061816363 Exp. 07/31/2024; 0061816364 Exp. 07/31/2024; 0061818516 Exp. 07/31/2024; 0061818517 Exp. 07/31/2024; 0061818518 Exp. 07/31/2024; 0061821562 Exp. 08/31/2024; 0061821563 Exp. 08/31/2024; 0061821564 Exp. 08/31/2024; 0061823709 Exp. 08/31/2024; 0061823710 Exp. 08/31/2024; 0061823711 Exp. 08/31/2024; 0061823714 Exp. 08/31/2024; 0061823715 Exp. 08/31/2024; 0061823716 Exp. 08/31/2024; 0061824770 Exp. 08/31/2024; 0061824771 Exp. 08/31/2024; 0061824772 Exp. 08/31/2024; 0061824773 Exp. 08/31/2024; 0061824774 Exp. 08/31/2024; 0061824775 Exp. 08/31/2024; 0061824776 Exp. 08/31/2024; 0061824777 Exp. 08/31/2024; 0061826486 Exp. 08/31/2024; 0061826487 Exp. 08/31/2024; 0061826488 Exp. 08/31/2024
Other Recalls from B. Braun Medical Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1083-2023 | Class III | 0.9% Sodium Chloride Injection USP, 1000 mL Exc... | Aug 2, 2023 |
| D-0916-2023 | Class II | 0.9% Sodium Chloride Injection USP, 1000 mL Exc... | Jul 5, 2023 |
| D-0347-2023 | Class II | 0.9% Sodium Chloride Injection, USP, 500 mL Exc... | Feb 10, 2023 |
Frequently Asked Questions
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
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.