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.
Reported: March 24, 2021 Initiated: March 11, 2021 #D-0305-2021
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Details
- Recalling Firm
- Sagent Pharmaceuticals Inc
- Units Affected
- 3716 cartons
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Schaumburg, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Sagent Pharmaceuticals Inc. Units affected: 3716 cartons.
Why was this product recalled? ▼
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 24, 2021. Severity: Moderate. Recall number: D-0305-2021.
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