The Recall Desk
HighFDA (Drugs)·D-0708-2023·Announced 2023-05-31

FDA Recalls Oxytocin Injection Bags Over Sterility Assurance Failure

Central Admixture Pharmacy Services is recalling 3,865 bags of oxytocin injection across the USA due to lack of sterility assurance identified during an FDA inspection. Sterile injectables must meet strict standards to prevent infection 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 a sterile injectable medication where sterility assurance could not be confirmed. While no illnesses or injuries have been reported, non-sterile injectable products pose a direct risk of serious infection; therefore, the recall qualifies as High severity.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 3,865 bags of oxytocin injection (15 units in 0.9% sodium chloride, 250 mL per bag) distributed nationwide in the USA. The recall was triggered after an FDA inspection raised questions about the sterility assurance of these products.

Oxytocin injection is a prescription medication intended for intravenous use. Products marketed as sterile injectables must meet rigorous standards to prevent contamination that could cause serious infections. The FDA inspection determined that the manufacturer could not adequately assure the sterility of the recalled batches.

Affected lot numbers range from 37-883926 (expiring 05/02/2023) through 37-898568 (expiring 06/29/2023). Consumers or healthcare providers who have received or administered this product should contact the manufacturer or their healthcare provider for guidance on safe handling and alternative treatment options. No illnesses have been reported to date.

The product is identified by NDC 72185-6042-1 and was manufactured by Central Admixture Pharmacy Services, Inc., located at 6580 Snowdrift Rd., Suite 100, Allentown, PA 18106.

The recalled product

Product
oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6042-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable / Intravenous
Hazard
  • sterility-failure
  • infection-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 # 37-883926
  • Exp 05/02/2023
  • 37-886032
  • Exp 05/10/2023
  • 37-887681
  • Exp 05/17/2023
  • 37-888317
  • Exp 05/21/2023
  • 37-890906
  • Exp 05/30/2023
  • 37-892146
  • Exp 06/05/2023
  • 37-892507
  • Exp 06/06/2023
  • 37-894483
  • Exp 06/13/2023
  • 37-896595
  • Exp 06/21/2023
  • 37-898568
  • Exp 06/29/2023

Distribution

Distributed nationwide across the United States.

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