Oxytocin and Lactated Ringer's Injection Recalled for Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 560 bags of oxytocin 15 units in Lactated Ringer's 250 mL after FDA inspection questioned the sterility of these products.
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 of a sterile injectable pharmaceutical product due to lack of assurance of sterility following FDA inspection. Since no illnesses or injuries are reported in the notice and the risk is theoretical at present, this is rated as High severity based on the product type and hazard category.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 560 bags of oxytocin 15 units added to Lactated Ringer's 250 mL per bag. The product is labeled "Rx only" and is intended to be sterile.
An FDA inspection raised questions about the sterility assurance of the products. This FDA Class II recall was initiated due to lack of assurance of sterility.
The affected lots are 37-891282 (expiration 05/06/2023) and 37-900124 (expiration 06/10/2023). These products were distributed nationwide in the United States.
Healthcare facilities and patients who may have received these products should contact their healthcare provider or the manufacturer for information about alternative treatment options or product return procedures.
The recalled product
- Product
- oxyTOCIN 15 units added to Lactated Ringer's 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6037-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- sterility-assurance
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 (4)
- Lot # 37-891282
- Exp 05/06/2023
- 37-900124
- Exp 06/10/2023
Distribution
Distributed nationwide across the United States.
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