The Recall Desk
Agency classClass IIOur severity: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.

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 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
Affected units
5,627

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.

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.

See all →

Same hazard · lack of sterility

See all →

Similar recalls