Sterile Injectable Drug Recall: oxyTOCIN in Lactated Ringer's IV Bags
Central Admixture Pharmacy Services is recalling 1,996 bags of oxyTOCIN in Lactated Ringer's IV bags because the company cannot assure the products are sterile. The firm lacks validation data for its sanitization procedures.
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: This is an FDA Class II recall of a sterile injectable drug with no reported illnesses or injuries. The hazard—contamination from inadequate sterilization validation—is a significant risk for intravenous solutions but remains theoretical until actual contamination is confirmed.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 1,996 bags of oxyTOCIN 30 units added to Lactated Ringer's 500 mL IV bags due to lack of assurance of sterility. The recall affects specific lot numbers: 36-260043, 36-260039 (exp. 9/8/2023), 36-262220 (exp. 9/10/2023), and 36-262526, 36-262525, 36-262524 (exp. 9/14/2023).
The reason for the recall is that the company lacked validation data to ensure that their sanitization cycles were adequate to achieve the required level of sterility. Without this validation, there is no assurance that the intravenous solutions were properly sterilized and are safe for patient use.
The recalled IV bags were distributed nationwide in the United States. Patients receiving these products should consult with their healthcare provider. Healthcare facilities should quarantine affected bags and contact Central Admixture Pharmacy Services or the FDA for instructions on proper handling and replacement.
The recalled product
- Product
- oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6039-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — IV Admixture
- Affected units
- 1,996
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 (9)
- Lot# 36-260043
- 36-260039
- Exp 9/8/2023
- 36-262220
- Exp 9/10/2023
- 36-262526
- 36-262525
- 36-262524
- Exp 9/14/2023.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 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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