Sagent Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Phenylephrine Hydrochloride Injection, USP, 10 mg/mL Due to Potential Lack of Sterility Assurance
WASHINGTON, DC – According to an FDA Recall Alert, Sagent Pharmaceuticals, Inc. has issued a nationwide recall of its Phenylephrine Hydrochloride Injection, USP, 10 mg/mL due to a possible breach in sterility leading to life-threatening infections. The March 11, 2021, announcement from Sagent Pharmaceuticals, Inc. states that the company is recalling three lots of its Phenylephrine Hydrochloride Injection, USP (10 mg/mL), due to a customer complaint regarding possible loose, crimped vial overseals. When a vial overseal is loose or crimped during the manufacturing process, the product may become non-sterile. The administration of intravenous products that are not sterile can cause severe systemic infections that could be life-threatening.
Phenylephrine Hydrochloride Injection, USP is classified as an alpha-1 adrenergic receptor agonist used for clinically important hypotension (low blood pressure) caused by blood vessel dilation a patient is under anesthesia. The recalled Phenylephrine Hydrochloride Injection is packaged in 3 mL glass tubular vials. The details of the affected products that were distributed to wholesalers, distributors, and hospitals nationwide in the U.S. from 11/17/2020 – 03/08/2021 are listed below.
- Product: Phenylephrine Hydrochloride Injection, USP
- Lot Numbers: PHT8IB2 PHT9IB2 PHT1JB2
- Expiration Dates: 08/2022, 08/2022, 09/2022
- NDC Number: 25021-315-01
- Distribution Dates: November 17, 2020 – March 8, 2021
Purchasers are being informed about the recall by email, fax, FedEx, and/or certified mail. The recall announcement will include details concerning the return process for the recalled products. Customers who have the recalled Phenylephrine Hydrochloride Injection are being instructed to immediately check their inventory, isolate and discontinue the distribution of the recalled products, and return the affected lots as described above. The necessary recall return form and other information regarding the recall can be found at www.Sagentpharma.com.
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