The Recall Desk
SevereFDA (Drugs)·D-0416-2022·Announced 2022-02-02

Edge Pharma Phenylephrine HCl IV Injection Sterility Assurance Recall

Edge Pharma is recalling Phenylephrine HCl 1mg/10mL single-use syringes for IV injection due to lack of assurance of sterility. The recall affects 6,535 vials distributed nationwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall involving lack of sterility assurance in an IV injection product. Class II recalls with risk of serious adverse health consequences in injectable drugs warrant a Severe classification per the rubric.

Plain-English summary

Edge Pharma, LLC is recalling Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, manufactured by Edge Pharma, LLC at 856 Hercules Dr, Colchester, VT 05446 (NDC 05446-1544-10). The recall affects 6,535 vials distributed nationwide.

The reason for recall is a lack of assurance of sterility. Affected lot codes are 08-2021-26@3 (dated 12/16/2021), 09-2021-16@5 (dated 12/29/2021), 10-2021-07@2 (dated 01/19/2022), and 10-2021-22@1 (dated 02/03/2022).

Patients and healthcare providers who have received or are using this product should discontinue use and contact Edge Pharma, LLC or the FDA for further guidance. The FDA has classified this as a Class II recall.

The recalled product

Product
Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446 NDC 05446-1544-10
Manufacturer
Edge Pharma, LLC
Category
Drug — Injectable / IV Administration
Hazard
  • sterility-assurance
  • 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)

  • 08-2021-26@3 12/16/2021
  • 09-2021-16@5 12/29/2021
  • 10-2021-07@2 01/19/2022 & 10-2021-22@1 02/03/2022.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category