Sagent Pharmaceuticals Inc: Drug Recall
Recall #D-0305-2021 · 03/11/2021
Class II: Risk
Recall Details
- Recall Number
- D-0305-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Sagent Pharmaceuticals Inc
- Status
- Terminated
- Date Initiated
- 03/11/2021
- Location
- Schaumburg, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3716 cartons
Reason for Recall
Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.
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.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Other Recalls by Sagent Pharmaceuticals Inc
- Class II: Risk 05/19/2023
- Class II: Risk 05/19/2023
- Class II: Risk 05/19/2023
- Class II: Risk 02/28/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.