The Recall Desk
HighFDA (Drugs)·D-1127-2023·Announced 2023-09-06

FDA Recalls Phenylephrine IV Bags Due to Unvalidated Sanitization

Central Admixture Pharmacy Services is recalling 292 bags of phenylephrine IV solution due to unvalidated sanitization cycles that cannot assure product sterility. No illnesses have been reported.

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: This is an FDA Class II recall of a parenteral drug product with no reported hospitalizations or illnesses. The hazard—unvalidated sanitization cycles—is a theoretical risk of contamination rather than documented harm. This fits the rubric criterion 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 292 bags of phenylephrine 40 mg/250 mL IV solution in 0.9% sodium chloride distributed nationwide. The recalled product is identified by NDC 72196-6092-1, Lot 36-260036, with an expiration date of 10/3/2023. This is a prescription-only intravenous infusion product.

The recall is due to a lack of validation data for the sanitization cycles used in the manufacturing of these IV bags. Without validated sanitization procedures, sterility of the product cannot be assured, creating a potential risk of microbial contamination in patients who receive this product.

Healthcare facilities that received this lot should immediately quarantine the product and ensure it is not administered to patients. Patients who may have received this product should consult with their healthcare provider. Any suspected adverse events should be reported to the FDA's MedWatch program or directly to the manufacturer.

No illnesses or injuries related to this product have been reported as of the date of this recall notice.

The recalled product

Product
PHENYLephrine, added to 0.9% sodium chloride, 40mg/250ml (160mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6092-1
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectables
Hazard
  • lack-of-sterility
  • contamination

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 (2)

  • Lot# 36-260036
  • Exp 10/3/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category