Phenylephrine injection lacks sterility assurance; FDA recalls vials
Nephron Sterile Compounding Center has recalled phenylephrine HCl injection vials due to lack of assurance of sterility. Patients and healthcare providers should discontinue use of the affected lots.
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 compounded medication with lack of sterility assurance. No illnesses or injuries have been reported in the source text, but the hazard poses a serious potential risk for an injectable product.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), supplied in 10 mL single-dose vials. The recall affects approximately 31,500 vials distributed nationwide in the USA due to lack of assurance of sterility.
The affected product is from lot PE2028 with expiration date 06/15/2023, manufactured at the Nephron 503B Outsourcing Facility in West Columbia, South Carolina (NDC 69374-305-10). This is a compounded injectable medication used in healthcare settings.
Healthcare providers and facilities that have received this product should stop dispensing and using the affected vials immediately. Patients currently using this medication should consult with their healthcare provider regarding appropriate alternative treatment options.
The recalled product
- Product
- Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-305-10.
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectable / Compounded
- Hazard
- lack-of-sterility
- contamination-risk
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 (2)
- Lots: PE2028
- Exp. 06/15/2023
Distribution
Distributed nationwide across the United States.
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