The Recall Desk
HighFDA (Drugs)·D-1013-2023·Announced 2023-08-09

Oxytocin IV bags recalled nationwide for insufficient sterility assurance

Central Admixture Pharmacy Services recalled 2,692 bags of oxytocin IV solution nationwide because the company lacks data needed to prove the sterilization process is effective.

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 IV medication due to unverified sterilization. Although no illnesses have been reported, lack of sterility assurance on an injectable product poses a significant potential risk, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 2,692 bags of oxytocin 40 units in 0.9% sodium chloride 1000 mL intravenous bags distributed nationwide. The recalled product includes multiple lot numbers with expiration dates ranging from July 2023 to September 2023: lots 36-241803 and 36-241804 (exp. 7/21/2023), 36-243836 (exp. 7/31/2023), 36-246645 (exp. 8/3/2023), 36-246729 (exp. 8/6/2023), 36-248976 (exp. 8/16/2023), 36-249502 (exp. 8/17/2023), 36-252215 (exp. 8/31/2023), and 36-255872 and 36-255875 (exp. 9/10/2023).

The recall is due to lack of assurance of sterility. The manufacturer lacks validation data demonstrating that decontamination cycles are effective, meaning the sterilization process cannot be verified. For intravenous medications, sterility is essential, and any lack of assurance of sterility creates a significant potential safety concern.

Healthcare providers and patients who have received or are currently using this product should contact their healthcare provider immediately for guidance. Medical facilities should identify any remaining product from the affected lot numbers and follow FDA guidance on proper quarantine and disposal.

The recalled product

Product
oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Intravenous
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 (18)

  • Lot: 36-241803
  • 36-241804
  • Exp. 7/21/2023
  • 36-243836
  • Exp. 7/31/2023
  • 36-246645
  • Exp. 8/3/2023
  • 36-246729
  • Exp. 8/6/2023
  • 36-248976
  • Exp. 8/16/2023
  • 36-249502
  • Exp. 8/17/2023
  • 36-252215
  • 8/31/2023
  • 36-255872
  • 36-255875
  • Exp. 9/10/2023

Distribution

Distributed nationwide across the United States.

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