FDA Recalls OxyTOCIN IV Bags Over Sterility Assurance Defect

Plain-English summary

Central Admixture Pharmacy Services, Inc. (CAPS, Inc.) is recalling 130,250 bags of oxyTOCIN 30 units added to 0.9% sodium chloride in 500 mL IV bags nationwide due to lack of assurance of sterility. The FDA found that validation data for the decontamination cycles used in manufacturing was lacking.

Affected lot numbers range from 36-238820 through 36-255615, with expiration dates from July 10, 2023, through September 7, 2023. The bags were distributed to hospitals and healthcare facilities across the United States.

Use of non-sterile IV medications carries a serious risk of infection. Patients who received doses from affected lots should contact their healthcare provider if they experience signs of infection. Healthcare facilities should immediately identify and remove affected lots from inventory and verify they are not administering any recalled product.

No illnesses or injuries have been reported in connection with these recalled IV bags.

The recalled product

Product

oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1

Manufacturer

Central Admixture Pharmacy Services, Inc.

Category

Drug — IV Infusion / Sterile Compounding

Hazard

• sterility-defect
• improper-sterilization

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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