Reported Jun 19, 2019 · Terminated
Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextrose Injection, 250 mL EXCEL Container bag,…
B. Braun Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: B. Braun Medical Inc · 2525 Mcgaw Ave · Irvine, CA · 92614-5841
Is this the product you have?
- 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.
- Lot codes and dates
Lot #: J7B259Exp 31 Aug 2019
- Amount recalled
- 40,176 bags
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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