The Recall Desk
SevereFDA (Drugs)·D-0418-2022·Announced 2022-02-02

Phenylephrine Injection Recall Due to Sterility Assurance Concerns

Edge Pharma is recalling phenylephrine injection (20 mg/250 mL) because the manufacturer cannot assure the product maintains sterility. The recall affects 3,930 bags 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 of a sterile injectable pharmaceutical product. Lack of sterility assurance in intravenous medications poses significant risk of serious infection and hospitalization, meeting the Severe criterion for Class II recalls with potential for serious harm.

Plain-English summary

Edge Pharma, LLC is recalling PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250 mL (0.08 mg/mL) in single-use bags for intravenous injection. The product is preservative-free and intended for prescription use.

The recall was initiated because the manufacturer cannot provide assurance that the product maintains sterility. Approximately 3,930 bags have been distributed nationwide with lot codes 08-2021-24@6 (12/06/2021), 08-2021-31@7 (12/12/2021), 09-2021-07@3 (12/21/2021), 10-2021-20@2 (02/02/2022), and 10-2021-28@2 (02/10/2022).

Healthcare providers and patients who have received or are holding this product should discontinue use and contact Edge Pharma, LLC at 856 Hercules Drive, Colchester, VT, for further instructions. Phenylephrine is used as a vasopressor to raise blood pressure; use of a non-sterile formulation poses a serious infection risk in intravenous administration.

The recalled product

Product
PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IV injection (Preservative Free), Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT NDC 05446-1667-01
Manufacturer
Edge Pharma, LLC
Category
Drug — Injectable / Vasopressor
Hazard
  • sterility-assurance
  • infection-risk
  • contamination-potential

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 (4)

  • 08-2021-24@6 12/06/2021
  • 08-2021-31@7 12/12/2021
  • 09-2021-07@3 12/21/2021
  • 10-2021-20@2 02/02/2022 & 10-2021-28@2 02/10/2022.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category