The Recall Desk
HighFDA (Drugs)·D-0711-2023·Announced 2023-05-31

Oxytocin Injectable Drug Recalled Over Sterility Assurance Concerns

Central Admixture Pharmacy Services is recalling 1,332 bags of oxytocin injectable solution due to FDA concerns about sterility assurance. The company could not confirm the product met sterility standards after an FDA inspection.

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 for an injectable drug where the manufacturer could not provide adequate assurance of sterility following an FDA inspection. Injectable medications with unconfirmed sterility pose a significant potential health risk, as contamination could lead to serious infections if administered to patients.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling oxytocin 60 units added to 0.9% sodium chloride in 1,000 mL bags. The recall was issued after an FDA inspection raised concerns about whether the company could provide adequate assurance that the product met sterility standards required for injectable medications. The affected product is sold as a prescription-only medication under NDC 71285-6045-1.

The recall affects 1,332 bags distributed nationwide in the United States. Six specific lot numbers are affected: 37-883073 (expires 04/28/2023), 37-887776 (expires 05/17/2023), 37-889209 (expires 05/23/2023), 37-892588 (expires 06/06/2023), 37-894449 (expires 06/13/2023), and 37-898552 (expires 06/29/2023).

Consumers and healthcare providers who have received this product should stop using it and contact Central Admixture Pharmacy Services for instructions on return or disposal. Patients should not use any remaining doses of the recalled product. Healthcare providers should review their inventory and alert patients who may have received this medication.

The recalled product

Product
oxyTOCIN 60 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6045-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectables
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 (12)

  • Lot # 37-883073
  • Exp 04/28/2023
  • 37-887776
  • Exp 05/17/2023
  • 37-889209
  • Exp 05/23/2023
  • 37-892588
  • Exp 06/06/2023
  • 37-894449
  • Exp 06/13/2023
  • 37-898552
  • Exp 06/29/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category