Phenylephrine HCl Injection recalled for lack of sterility assurance
Nephron Sterile Compounding Center is recalling Phenylephrine HCl Injection syringes nationwide due to lack of assurance of sterility affecting 76,860 units.
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 is an FDA Class II recall of an injectable medication with potential contamination risk due to lack of sterility assurance. No illnesses or injuries have been reported. The hazard represents a risk of harm to patients if administered, qualifying it as High severity per the rubric.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection, USP, 0.8 mg/10 mL due to lack of assurance of sterility. The recall affects 76,860 pre-filled syringes distributed nationwide. Affected lot numbers are PE1107A, PE1123A, PE2007A, and PE2012A, with expiration dates ranging from May 2022 to August 2022.
The manufacturer initiated the recall because it could not provide assurance that the product meets required sterility standards. Phenylephrine HCl Injection is an injectable medication. Patients and healthcare providers in possession of syringes from the affected lots should stop use immediately and contact Nephron Sterile Compounding Center or their healthcare provider for guidance on replacement or return of the product.
Anyone who has used this product and experienced adverse effects should report the event to the FDA's MedWatch program.
The recalled product
- Product
- Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled Syringes, 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: 69374-956-10
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 76,860
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 (8)
- Lots: PE1107A
- Exp. 5/22/2022
- PE1123A
- Exp. 6/21/2022
- PE2007A
- Exp. 8/4/2022
- PE2012A
- Exp. 8/28/2022
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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