Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 m...
FDA Drug Recall #D-1343-2019 — Class II — June 13, 2019
Recall Summary
| Recall Number | D-1343-2019 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 13, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | B. Braun Medical Inc |
| Location | Irvine, CA |
| Product Type | Drugs |
| Quantity | 40,176 bags |
Product Description
Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 mL EXCEL Container bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018-3524 USA, API from SPAIN, NDC 0264-9587-20.
Reason for Recall
Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa potency which is intended to ensure that the potency of heparin is within the USP specifications.
Distribution Pattern
Nationwide in the USA
Lot / Code Information
Lot #: J7B259, Exp 31 Aug 2019
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 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.