FDAFDA · Food and drugs·Recall number D-0305-2021
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. for: SAGENT Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC: 25021-315-01.
Published March 24, 2021 · Recall initiated: March 11, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Brand
- PHENYLEPHRINE HYDROCHLORIDE
- Manufacturer
- Sagent Pharmaceuticals Inc
- Distributor
- Nationwide in the USA and Puerto Rico
- Lot
- Lots: PHT8IB2, PHT9IB2, exp 08/2022; PHT1JB2, exp 09/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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