IV Oxytocin Solution Recall Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 9,504 IV bags of oxytocin mixed with Lactated Ringer's solution because validation data for sterilization cycles is lacking. The product was distributed nationwide.
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 of an injectable medication with no reported illnesses, injuries, or confirmed contamination—only validation data gaps. Per the rubric, risk-of-harm products without reported injury are scored at 3.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling oxytocin 20 units admixed with Lactated Ringer's 1000 mL intravenous bags (NDC 72196-6038-1). The product was manufactured and distributed nationwide.
The recall was initiated because validation data for decontamination cycles is lacking, creating uncertainty about whether sterilization processes were adequate to ensure the sterility of these injectable products.
The recall affects 9,504 IV bags distributed across multiple lot numbers with expiration dates ranging from July through August 2023.
Healthcare facilities and individuals should discontinue use of affected batches immediately. Contact your pharmacy or healthcare provider for guidance on affected lot numbers and replacement products.
The recalled product
- Product
- oxyTOCIN 20 units added to Lactated Ringer's 1000 mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6038-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable / IV Solution
- Hazard
- 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 (20)
- Lot: 36-247256
- 36-247525
- 36-247259
- Exp. 7/14/2023
- 36-247782
- 36-247784
- Exp. 7/15/2023
- 36-247980
- Exp. 7/16/2023
- 36-248274
- 36-248275
- Exp. 7/19/2023
- 36-248732
- 36-248733
- 36-248734
- 36-248735
- Exp. 7/21/2023
- 36-248971
- 36-248990
- Exp. 7/22/2023
Distribution
Distributed nationwide across the United States.
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