The Recall Desk
HighFDA (Drugs)·D-0702-2023·Announced 2023-05-31

OxyTOCIN-dextrose injectable recalled nationwide for sterility assurance concerns

Central Admixture Pharmacy Services is recalling oxyTOCIN 20 units in dextrose 5%/Lactated Ringer's solution nationwide due to lack of sterility assurance identified during FDA inspection. 7,595 bags across multiple lot numbers are affected.

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 involving an injectable drug with questioned sterility assurance. While no illnesses have been reported, an injectable medication lacking sterile conditions constitutes a risk-of-harm product, meeting the rubric criterion for High severity.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling oxyTOCIN 20 units added to dextrose 5% in Lactated Ringer's solution, 1,000 mL per bag. The product is an injectable medication used in obstetric care, with 7,595 bags affected across multiple lot numbers.

The FDA determined during an inspection that the company could not provide adequate assurance of sterility for these products. Sterility is essential for injectable medications to prevent infection.

The affected product was distributed nationwide across the United States. Affected lot numbers have expiration dates ranging from April 30, 2023 through June 21, 2023.

Healthcare facilities and providers should verify whether they have any of the affected lot numbers in inventory. Any remaining stock should not be used.

The recalled product

Product
oxyTOCIN 20 units added to dextrose 5%/Lactated Ringer's 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6031-1.
Manufacturer
Central Admixture Pharmacy Services, Inc.
Category
Drug — Injectable
Hazard
  • sterility-concern
  • 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 # 37-883206
  • 37-883207
  • 37-883210
  • 37-883213
  • 37-883216
  • 37-883217
  • Exp 04/30/2023
  • 37-884447
  • 37-884450
  • Exp 05/04/2023
  • 37-886269
  • Exp 05/11/2023
  • 37-887516
  • Exp 05/16/2023
  • 37-888306
  • 37-888308
  • 37-888310
  • 37-888311
  • Exp 05/21/2023
  • 37-890097

Distribution

Distributed nationwide across the United States.

Related recalls

Same category