Reported Sep 28, 2016 · Terminated
Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per…
Sandoz 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: Sandoz Inc · 100 College Rd W · Princeton, NJ · 08540-6604
Is this the product you have?
- Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02), Rx only
- Manufactured forSandoz Inc., Princeton, NJ 08540
- Lot codes and dates
Lot #: 080514080614081114081214081314081414082714082814082914Exp 08/16090214090314090814090914091014091114091214091514Exp 09/16
- Amount recalled
- 32,099 cartons
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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