The Recall Desk
HighFDA (Drugs)·D-0737-2023·Announced 2023-05-31

Diphenhydramine 25 mg intravenous bags recalled for lack of sterility assurance

Central Admixture Pharmacy Services recalls 5,627 bags of diphenhydramine 25 mg intravenous solution nationwide. An FDA inspection called into question the sterility of the products intended to be sterile.

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 without reported illnesses or hospitalization reports. The hazard—lack of sterility assurance in a pharmaceutical product intended to be sterile—constitutes a risk-of-harm situation where injury has not yet been reported, meeting the criteria for Score 3 (High) per the severity rubric.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling diphenhydramine 25 mg added to 0.9% sodium chloride in 50 mL partial additive bags. Approximately 5,627 bags across multiple lot numbers are affected, distributed nationwide. The product is intended for healthcare use as a pharmaceutical admixture.

During an FDA inspection, the sterility of these products intended to be sterile was called into question. The manufacturer could not provide assurance that sterility standards were maintained. Partial additive bags are used in healthcare settings and must remain sterile to prevent infections when administered to patients.

Healthcare facilities that received this product should stop using affected lots immediately and contact the manufacturer or distributor. Patients who received an injection from affected lots should contact their healthcare provider if they experience signs of infection or other adverse effects.

The recalled product

Product
diphenhydrAMINE 25 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7089-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Intravenous Admixture
Hazard
  • lack-of-sterility

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 # 37-884145
  • 37-884154
  • Exp 05/03/2023
  • 37-885931
  • Exp 05/10/2023
  • 37-888293
  • Exp 05/21/2023
  • 37-889057
  • 37-889063
  • Exp 05/23/2023
  • 37-891437
  • Exp 06/01/2023
  • 37-893455
  • Exp 06/11/2023
  • 37-893788
  • Exp 06/12/2023
  • 37-894302
  • Exp 06/13/2023
  • 37-894652
  • Exp 06/14/2023

Distribution

Distributed nationwide across the United States.

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