The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0724-2023·Announced 2023-05-31

FDA Recalls Injectable Phenylephrine Solution Due to Sterility Assurance Issue

Central Admixture Pharmacy Services is recalling 14,205 bags of injectable phenylephrine solution nationwide following FDA inspection findings regarding sterility assurance. The product is prescription-only with nationwide distribution.

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 due to lack of sterility assurance, representing significant risk to patients. No illnesses or injuries are reported in the source, meeting the criteria for High severity: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 14,205 bags of injectable phenylephrine solution nationwide. The product is phenylephrine 40 mg per 250 mL added to 0.9% sodium chloride solution (160 mcg/mL), supplied in 250 mL bags for intravenous administration, NDC 71285-6092-1.

The recall was initiated because an FDA inspection called into question the sterility of the products intended to be sterile. The affected product has been distributed nationwide.

Multiple lot numbers are affected, with expiration dates ranging from May 2023 through June 2023. The recalled lots include 37-883910 (Exp 05/02/2023), 37-884221 (Exp 05/03/2023), 37-884756 (Exp 05/05/2023), 37-885358 (Exp 05/08/2023), 37-885683 (Exp 05/09/2023), and others through 37-896923 (Exp 06/22/2023).

Healthcare providers should quarantine remaining product and contact Central Admixture Pharmacy Services or the FDA with questions about this recall.

The recalled product

Product
PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6092-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable Solution
Hazard
Affected units
14,205

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 # 37-883910
  • Exp 05/02/2023
  • 37-884221
  • Exp 05/03/2023
  • 37-884756
  • Exp 05/05/2023
  • 37-885358
  • Exp 05/08/2023
  • 37-885683
  • Exp 05/09/2023
  • 37-886267
  • 37-886268
  • Exp 05/11/2023
  • 37-886539
  • Exp 05/14/2023
  • 37-887458
  • 37-887459
  • Exp 05/16/2023
  • 37-888080
  • Exp 05/18/2023

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 →

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