Agency classClass IIOur severity:Severe FDA (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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Affected units: 3,930

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.

Part of a larger recall action

This product is one of 56 recalled by Edge Pharma, 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.

See all 56 products in this recall →

Same manufacturer · Edge Pharma, LLC

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