Phenylephrine HCl Injection Recalled for Lack of Sterility Assurance
Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection due to lack of assurance of sterility. Approximately 57,810 syringes were distributed nationwide.
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 a Class II FDA recall with no reported illnesses or injuries and a theoretical hazard (lack of assurance rather than confirmed contamination). Lack of sterility assurance in injectable products constitutes a risk-of-harm situation, supporting a High severity rating.
Plain-English summary
Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection, USP 0.4 mg/10 mL (40 mcg/mL), due to lack of assurance of sterility. The U.S. Food and Drug Administration classified this as a Class II recall.
The affected product includes lots PE1108A (expiration 5/27/2022), PE2006A (expiration 8/3/2022), and PE2010A (expiration 8/12/2022). Approximately 57,810 syringes were distributed nationwide in the United States.
Lack of assured sterility in injectable medications poses a potential safety risk. Healthcare providers and facilities who may have received product from the affected lots should contact Nephron Sterile Compounding Center LLC or the FDA for further guidance.
The recalled product
- Product
- Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 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: 69374-955-10
- Manufacturer
- Nephron Sterile Compounding Center LLC
- Category
- Drug — Injectable
- Hazard
- sterility-assurance
- contamination
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 (6)
- Lots: PE1108A
- Exp. 5/27/2022
- PE2006A
- Exp. 8/3/2022
- PE2010A
- Exp. 8/12/2022
Distribution
Distributed nationwide across the United States.
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