Phenylephrine HCl Injection Recalled Due to Sterility Assurance Failure
Nephron Sterile Compounding Center is recalling Phenylephrine HCl Injection syringes nationwide because the manufacturer cannot assure the product met sterility standards required for injectable medications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an injectable drug where sterility cannot be assured. While the hazard presents significant infection risk, no illnesses or injuries are reported, meeting the criteria for Score 3: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection, USP (1 mg/10 mL) syringes distributed nationwide due to a lack of assurance of sterility. The recall affects 585,660 syringes across multiple lot numbers with expiration dates from May 2022 through September 2022.
Sterility is a critical requirement for injectable medications. The manufacturer was unable to provide assurance that the affected product met required sterility standards, prompting this recall.
Patients and healthcare providers in possession of affected syringes should not use them. Contact a healthcare provider if the recalled medication has already been administered. Return unused syringes to your pharmacy or healthcare facility for proper disposal.
The recalled product
- Product
- Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-957-10
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Compounded Injectable
- Affected units
- 585,660
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- Lots: PE1115B
- PE1115C
- Exp. 5/31/2022
- PE1122A
- Exp. 6/19/2022
- PE2004B
- PE2004C
- Exp. 7/11/2022
- PE2011A
- PE2011C
- Exp. 8/22/2022
- PE2015A
- PE2015B
- PE2015C
- Exp. 9/5/2022
- PE2016A
- PE2016B
- PE2016C
- Exp. 9/13/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by Nephron Sterile Compounding Center LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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