The Recall Desk
HighFDA (Drugs)·D-0979-2023·Announced 2023-08-09

Heparin IV Bags Recalled for Lack of Sterility Assurance

Central Admixture Pharmacy Services is recalling 5,834 bags of heparin 5000 units/500mL IV bags nationwide due to insufficient validation of sterilization processes, creating potential contamination risk.

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 an intravenous medication affecting sterility assurance—a high-risk product. No illnesses, injuries, or hospitalizations are reported in the source. Per the severity rubric, 'risk-of-harm products where injury has not yet been reported' receive a Score 3 (High).

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 5,834 bags of heparin 5000 units/500mL added to 0.9% sodium chloride (10 units/mL, IV bags). The product carries NDC 72196-7023-1 and was distributed nationwide throughout the USA.

The recall was initiated because the manufacturer lacks sufficient validation data for decontamination cycles, preventing assurance that products meet required sterility standards for intravenous administration. Heparin is an anticoagulant medication administered intravenously in clinical settings. Non-sterile injectable medications pose serious health risks to patients, including potential bacterial contamination or other pathogens.

Affected lots include: 36-246161 (Exp. 7/14/2023); 36-247002, 36-247006, 36-247007 (Exp. 7/18/2023); 36-247673, 36-247674 (Exp. 7/20/2023); 36-247832, 36-247833, 36-247835, 36-247836 (Exp. 7/21/2023); 36-248991 (Exp. 7/27/2023); 36-249593 (Exp. 7/29/2023); 36-250046 (Exp. 8/2/2023); 36-251444, 36-251445, 36-251446, 36-251447 (Exp. 8/8/2023); 36-251968 (Exp. 8/10/2023); 36-254379, 36-254380 (Exp. 8/15/2023); and 36-254684 (Exp. 8/16/2023).

Healthcare facilities should immediately discontinue use of affected lots and quarantine remaining inventory. Consult with distributors and providers regarding proper handling and patient follow-up if doses were administered.

The recalled product

Product
heparin 5000 units/500mL added to 0.9% sodium chloride, 10 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7023-1
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Intravenous Medication
Hazard
  • lack-of-sterility
  • contamination-risk

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: 36-246161
  • Exp. 7/14/2023
  • 36-247002
  • 36-247006
  • 36-247007
  • Exp. 7/18/2023
  • 36-247673
  • 36-247674
  • Exp. 7/20/2023
  • 36-247832
  • 36-247833
  • 36-247835
  • 36-247836
  • Exp. 7/21/2023
  • 36-248991
  • Exp. 7/27/2023
  • 36-249593
  • Exp. 7/29/2023
  • 36-250046
  • Exp. 8/2/2023

Distribution

Distributed nationwide across the United States.

Related recalls

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