The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0713-2023·Announced 2023-05-31

Injectable Diltiazem Recalled Over Sterility Assurance Concerns from FDA Inspection

Central Admixture Pharmacy Services is recalling 3,040 bags of prescription diltiazem injection after FDA inspection raised concerns about product sterility. The medication was distributed nationwide.

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: FDA Class II recall of a sterile injectable product where inspection confirmed concerns about sterility assurance. No illnesses or injuries have been reported, but loss of sterility assurance in an injectable medication presents significant risk of contamination and serious infection.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 3,040 bags of diltiazem added to 0.9% sodium chloride (125 mg/125 mL, 125 mL per bag). This is a prescription injectable medication.

The recall was initiated after a U.S. Food and Drug Administration (FDA) inspection raised concerns about whether the product meets sterility standards required for injectable medications. Injectable drugs must be sterile and free of harmful microorganisms to ensure patient safety. No illnesses or injuries have been reported in connection with this recall.

The affected product was distributed nationwide. The recalled lot numbers with expiration dates are: 37-896374, 37-896375 (05/31/2023); 37-896876, 37-896878 (06/02/2023); 37-897077, 37-897078 (06/05/2023); 37-900074, 37-900075, 37-900076, 37-900111, 37-900112, 37-900115 (06/15/2023); and 37-900328 (06/16/2023).

Healthcare providers and patients who have the recalled product should contact their pharmacy or healthcare provider immediately for instructions. Do not use any of the recalled lot numbers.

The recalled product

Product
dilTIAZem added to 0.9% sodium chloride, 125 mg/125 mL* (1 mg/mL), 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6055-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable medication
Hazard
Affected units
3,040

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 (18)

  • Lot # 37-896374
  • 37-896375
  • Exp 05/31/2023
  • 37-896876
  • 37-896878
  • Exp 06/02/2023
  • 37-897077
  • 37-897078
  • Exp 06/05/2023
  • 37-900074
  • 37-900075
  • 37-900076
  • 37-900111
  • 37-900112
  • 37-900115
  • Exp 06/15/2023
  • 37-900328
  • Exp 06/16/2023

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 →

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