FDA Recalls OxyTOCIN IV Bags Over Sterility Assurance Defect
FDA recalls 130,250 bags of oxyTOCIN IV solution from CAPS, Inc., distributed nationwide, due to lack of validated sterilization procedures. No illnesses reported.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 drug product with risk of serious infection from potential lack of sterility. However, no illnesses or injuries have been reported, and the hazard is based on insufficient validation data rather than confirmed contamination.
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.
- Affected units
- 130,250
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: 36-238820
- 36-238821
- 36-238822
- 36-238824
- 36-238825
- Exp. 7/10/2023
- 36-239686
- 36-239687
- 36-239688
- 36-239689
- 36-239690
- 36-239691
- 36-239692
- 36-239693
- 36-239696
- 36-239697
- 36-239699
- 36-239700
- Exp. 7/12/2023
- 36-239915
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 95 recalled by Central Admixture Pharmacy Services, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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