The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0733-2023·Announced 2023-05-31

Phenylephrine Injectable Solution Recalled Over Sterility Assurance Failure

Central Admixture Pharmacy Services recalls 13,953 bags of phenylephrine injectable solution nationwide due to FDA concerns about sterility assurance identified during inspection.

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 3/5 (High).

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: This is an FDA Class II recall of a sterile injectable product with sterility assurance concerns. No illnesses or injuries have been reported in the source. Per the severity rubric, Class II recalls without reported illness and with theoretical hazards score at most High (3).

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 13,953 bags of phenylephrine added to 0.9% sodium chloride injectable solution (NDC 71285-7025-1), distributed nationwide.

The recall was initiated after an FDA inspection raised questions about whether the product maintains sterility assurance, which is critical for injectable medications. No illnesses or injuries have been reported.

The affected lots have expiration dates ranging from April 28, 2023 to June 29, 2023. Individuals and healthcare facilities using this product should stop immediately and contact their healthcare provider or pharmacist about alternatives. Unused product should be returned to Central Admixture Pharmacy Services or disposed of per FDA guidance.

The recalled product

Product
PHENYLephrine added to 0.9% sodium chloride, 20 mg/250 mL* (80 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7025-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable Solution
Hazard
Affected units
13,953

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 # 37-883074
  • Exp 04/28/2023
  • 37-883237
  • 37-883238
  • Exp 04/30/2023
  • 37-883940
  • Exp 05/02/2023
  • 37-884271
  • Exp 05/03/2023
  • 37-884749
  • 37-884751
  • Exp 05/05/2023
  • 37-885338
  • Exp 05/08/2023
  • 37-885756
  • Exp 05/09/2023
  • 37-886272
  • Exp 05/11/2023
  • 37-887512
  • Exp 05/16/2023

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 · lack of sterility

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