The Recall Desk
HighFDA (Drugs)·D-0703-2023·Announced 2023-05-31

OxyTOCIN Injectable Product Recalled for Sterility Assurance Concerns

Central Admixture Pharmacy Services is recalling 2624 bags of oxyTOCIN due to FDA concerns about product sterility. 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: FDA Class II recall of an injectable drug following questions about sterility assurance. No illnesses or injuries reported; this meets the rubric criterion for risk-of-harm products where injury has not yet been reported, warranting a High (3) severity score.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling oxyTOCIN 30 units added to dextrose 5%/Lactated Ringer's 500 mL per bag. The recall affects 2624 bags distributed nationwide across seven different lots with expiration dates ranging from May through June 2023.

The recall was initiated after an FDA inspection questioned whether the products maintained their required sterility. Because these are injectable medications intended to be sterile, any compromise to sterility assurance poses a potential health risk.

Healthcare facilities and patients should stop using the affected product immediately. Institutions with the recalled lots should contact their pharmacy or the manufacturer for guidance on proper product return or destruction. Affected patients should consult their healthcare provider about alternative medication options.

The recalled product

Product
oxyTOCIN 30 units added to dextrose 5%/Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6032-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Sterile Injectable
Hazard
  • sterility-assurance
  • 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 (15)

  • Lot # 37-883948
  • Exp 05/02/2023
  • 37-886037
  • 37-886040
  • Exp 05/10/2023
  • 37-889593
  • Exp 05/24/2023
  • 37-891270
  • Exp 05/31/2023
  • 37-893223
  • Exp 06/08/2023
  • 37-896230
  • Exp 06/20/2023
  • 37-898520
  • Exp 06/29/2023

Distribution

Distributed nationwide across the United States.

Related recalls

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