Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Phenylephrine HCl Injection Recalled by Sagent Pharmaceuticals Inc Due to Lack of Assurance of Sterility: customer complaints of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sagent Pharmaceuticals Inc directly.
Affected Products
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.
Quantity: 3716 cartons
Why Was This Recalled?
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sagent Pharmaceuticals Inc
Sagent Pharmaceuticals Inc has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report