FDA recalls oxytocin-lactated ringer IV bags due to sterility concerns
Central Admixture Pharmacy Services recalls 33,073 bags of oxytocin 30 units with Lactated Ringer's 500 mL IV solution nationwide due to lack of validated sterilization. No illnesses reported.
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: FDA Class II recall involving a risk-of-harm product (injectable medication) where no illnesses or injuries have been reported. Lack of validated sterilization in an intravenously administered drug represents a serious potential contamination risk.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 33,073 bags of oxytocin 30 units added to Lactated Ringer's 500 mL IV bags due to lack of assurance of sterility. The manufacturer lacks validation data to confirm that its decontamination cycles are effective.
The affected product was distributed nationwide. Multiple lot numbers are involved, with expiration dates ranging from July 13, 2023, through August 11, 2023. The product is a prescription-only intravenous preparation.
Consumers and healthcare providers who have this product should discontinue use and contact Central Admixture Pharmacy Services, Inc., or the FDA with questions. No illnesses or injuries related to this product have been reported.
The recalled product
- Product
- oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6039-1
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-failure
- contamination
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: 36-247353
- Exp. 7/13/2023
- 36-247260
- 36-247261
- 36-247262
- Exp. 7/14/2023
- 36-248215
- 36-248218
- 36-248222
- Exp. 7/19/2023
- 36-248861
- 36-248862
- 36-248863
- 36-248865
- Exp. 7/21/2023
- 36-249513
- 36-249514
- 36-249659
- 36-249693
- Exp. 7/24/2023
Distribution
Distributed nationwide across the United States.
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