The Recall Desk
HighFDA (Drugs)·D-0727-2023·Announced 2023-05-31

FDA Recalls Phenylephrine Injectable Due to Sterility Concerns

Central Admixture Pharmacy Services is recalling 5,304 bags of phenylephrine injection nationwide after FDA inspection raised concerns about product sterility assurance.

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: FDA Class II recall of injectable medication with potential sterility issues. No illnesses or injuries reported; the hazard is based on lack of sterility assurance following FDA inspection. This is a risk-of-harm product without reported injury, scoring at the High level per the rubric.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 5,304 bags of phenylephrine injection (25 mg per 250 mL in 0.9% sodium chloride, 100 mcg/mL). The recall was initiated after an FDA inspection called into question the sterility assurance of these injectable products.

The affected product was distributed nationwide throughout the United States. Twelve different lot numbers are included in this recall, with expiration dates ranging from May 2, 2023 to June 29, 2023. The product is identified by NDC 71285-7011-1.

No illnesses or injuries have been reported in connection with this recall. The issue was identified through FDA inspection of the manufacturer's processes.

The recalled product

Product
PHENYLephrine added to 0.9% sodium chloride, 25 mg/250 mL* (100 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7011-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable
Hazard
Affected units
5,304

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 (20)

  • Lot # 37-883924
  • Exp 05/02/2023
  • 37-884918
  • Exp 05/07/2023
  • 37-885677
  • Exp 05/09/2023
  • 37-887318
  • Exp 05/16/2023
  • 37-889211
  • Exp 05/23/2023
  • 37-889848
  • Exp 05/25/2023
  • 37-891150
  • Exp 05/31/2023
  • 37-892482
  • Exp 06/06/2023
  • 37-894484
  • Exp 06/13/2023
  • 37-896458
  • 37-896480

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 108 recalled by Central Admixture Pharmacy Services, Inc. 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 108 products in this recall →

Related recalls

Same manufacturer · Central Admixture Pharmacy Services, Inc.

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Same hazard · sterility

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