Phenylephrine injection recalled due to lack of sterility assurance
Nephron Sterile Compounding Center is recalling Phenylephrine HCl injection nationwide due to lack of assurance of sterility. Lot PS2008A with expiration 03/07/2023 is affected.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 FDA Class II recall addresses lack of sterility assurance in injectable medication. No illnesses or injuries have been reported. The classification meets the severity rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl in 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The product is distributed nationwide as 250 mL single-dose bottles in cartons of 15 (NDC 69374-321-25).
The FDA classified this as a Class II recall. Lot PS2008A, which expires 03/07/2023, affects 10,980 bottles. The recall was issued because sterility could not be confirmed for this lot.
Healthcare providers and facilities in receipt of this medication should verify their inventory against the affected lot number and discontinue use if present.
The recalled product
- Product
- Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-321-25.
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectable / Intravenous
- Affected units
- 10,980
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: PS2008A
- Exp. 03/07/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 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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