The Recall Desk
HighFDA (Drugs)·D-0738-2023·Announced 2023-05-31

FDA Recalls Diphenhydramine Injectable for Sterility Assurance Deficiency

Central Admixture Pharmacy Services is recalling 3,999 units of diphenhydramine injectable due to sterility assurance concerns identified during an FDA inspection. 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 sterile injectable products due to questioned sterility assurance from an FDA inspection. Although no illnesses or injuries have been reported, sterile injectable medications with potential contamination represent a risk-of-harm product per the rubric, warranting a High severity score.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling diphenhydramine 50 mg in 0.9% sodium chloride 50 mL in 100 mL Partial Additive Bags (NDC 71285-7090-1). A total of 3,999 bags are affected, distributed nationwide in the USA.

The recall was initiated after an FDA inspection raised questions about the sterility of products intended to be sterile. Lack of adequate sterility assurance can pose a significant risk to patients who receive these injectable medications.

This product is available only by prescription and is distributed to healthcare facilities. Healthcare providers who have received affected lots should discontinue use immediately. Affected lot numbers include 37-884155 (Exp 05/03/2023), 37-885992 (Exp 05/10/2023), 37-887348 (Exp 05/16/2023), 37-887660 (Exp 05/17/2023), 37-889052 (Exp 05/23/2023), 37-891155 and 37-891156 (Exp 05/31/2023), 37-891443 (Exp 06/01/2023), and 37-892475 (Exp 06/06/2023). Patients or healthcare providers with questions should contact the recalling firm.

The recalled product

Product
diphenhydrAMINE 50 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 71285-7090-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Sterile Injectable
Hazard
  • sterility-failure

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 (17)

  • Lot # 37-884155
  • Exp 05/03/2023
  • 37-885992
  • Exp 05/10/2023
  • 37-887348
  • Exp 05/16/2023
  • 37-887660
  • Exp 05/17/2023
  • 37-889052
  • Exp 05/23/2023
  • 37-891155
  • 37-891156
  • Exp 05/31/2023
  • 37-891443
  • Exp 06/01/2023
  • 37-892475
  • Exp 06/06/2023

Distribution

Distributed nationwide across the United States.

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