Reported Mar 24, 2021 · Terminated
Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per…
Sagent Pharmaceuticals 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: Sagent Pharmaceuticals Inc · 1901 N Roselle Rd Ste 450 · Schaumburg, IL · 60195-3194
Is this the product you have?
- Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton, For Intravenous Use, Rx only, Mfd
- forSAGENT Pharmaceuticals, Schaumburg, IL 60195; Made in India
- NDC25021-315-01
- Lot codes and dates
- Lots
PHT8IB2PHT9IB2exp 08/2022PHT1JB2exp 09/2022
- Lots
- Amount recalled
- 3716 cartons
Where it was sold
- Nationwide
- PR
Why it was recalled
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
This product could cause temporary or reversible health problems — stop using it.
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