The Recall Desk
HighFDA (Drugs)·D-0417-2022·Announced 2022-02-02

Phenylephrine HCl Injection Recalled Due to Lack of Sterility Assurance

Edge Pharma is recalling approximately 5,335 syringes of Phenylephrine HCl Sterile Solution for Injection nationwide due to lack of assurance of sterility. The product may not meet sterility requirements for safe use.

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: The source text indicates this is an FDA Class II recall involving a sterile injectable product with loss of sterility assurance. Although no illnesses or injuries are reported in the source, the failure of sterility assurance in an injection product represents a significant risk of harm to patients who may receive a non-sterile product, meeting the High severity threshold.

Plain-English summary

Edge Pharma, LLC is recalling Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), Single Use Syringe for IV Injection, NDC 05446-1652-01, manufactured at 856 Hercules Dr., Colchester, VT 05446. Approximately 5,335 syringes are affected by this recall.

The recall was initiated due to lack of assurance of sterility. Phenylephrine HCl is an injectable drug product, and loss of sterility assurance poses a potential risk to patients who receive the product.

Affected batches include the following lot codes: 08-2021-27@4 (12/09/2021), 09-2021-17@1 (12/30/2021), 10-2021-15@1 (01/27/2022), and 10-2021-28@1 (02/09/2022). The product was distributed nationwide.

Healthcare providers and patients who have received this product should consult with their healthcare provider regarding appropriate follow-up care. The product should not be administered.

The recalled product

Product
Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), Single Use Syringe for IV Injection, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1652-01
Manufacturer
Edge Pharma, LLC
Category
Drug — Injectable Solution
Hazard
  • sterility-assurance-loss
  • 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 (3)

  • 08-2021-27@4 12/09/2021
  • 09-2021-17@1 12/30/2021
  • 10-2021-15@1 01/27/2022 & 10-2021-28@1 02/09/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category