The Recall Desk
HighFDA (Drugs)·D-1077-2023·Announced 2023-08-09

Phenylephrine Injectable Syringes Recalled Due to Sterility Validation Deficiency

Central Admixture Pharmacy Services recalled phenylephrine injectable syringes nationwide due to missing validation data for sanitization cycles. Approximately 10,494 syringes from multiple lots may not meet sterility assurance standards.

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 involving an injectable pharmaceutical product. The hazard—lack of validated sterilization assurance—is theoretical with no reported illnesses or injuries. Per the severity rubric, injectable medications with sterility concerns qualify as 'High' risk even without confirmed harm, as sterility assurance is critical for patient safety.

Plain-English summary

Central Admixture Pharmacy Services Inc is recalling 10,494 syringes containing phenylephrine 800 mcg in 0.9% sodium chloride (80 mcg/mL) distributed nationwide. The recall was initiated due to lack of validation data for sanitization cycles, which compromises assurance that the products meet required sterility standards for injectable medications.

The affected product is a prescription injectable medication supplied in 10 mL syringes. Multiple lot numbers are involved, with expiration dates ranging from July 18, 2023 through September 13, 2023. Healthcare facilities and pharmacies that received these syringes should discontinue use immediately.

No illnesses or injuries related to this product have been reported to date. Healthcare providers and patients who have received this medication should contact their healthcare provider or the manufacturer for guidance. Unused units should not be dispensed or administered.

The recalled product

Product
PHENYLephrine in 0.9 sodium chloride, 800 mcg /10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6008-1
Manufacturer
Central Admixture Pharmacy Services Inc
Category
Drug — Injectable / Prescription
Hazard
  • sterility-assurance

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: 17-270678
  • 17-270695
  • Exp. 7/18/2023
  • 17-270880
  • Exp. 7/20/2023
  • 17-271075
  • Exp. 7/24/2023
  • 17-271233
  • 17-271269
  • Exp. 7/26/2023
  • 17-271492
  • 17-271494
  • Exp. 7/31/2023
  • 17-271748
  • Exp. 8/3/2023
  • 17-271891
  • Exp. 8/7/2023
  • 17-271945
  • Exp. 8/8/2023
  • 17-272221

Distribution

Distributed nationwide across the United States.

Related recalls

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