FDA recalls oxytocin admixture bags for lack of sterility assurance
Central Admixture Pharmacy Services is recalling 2,186 bags of oxytocin intravenous admixture nationwide due to lack of sterility assurance following an FDA inspection.
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 involving a sterile injectable medication. The source text does not report any illnesses or injuries, making the hazard theoretical rather than confirmed. This meets the criteria for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling oxyTOCIN 40 units added to 0.9% sodium chloride 1,000 bag (NDC 71285-8069-1), a prescription-only intravenous product. The recall affects 2,186 bags that were distributed nationwide.
An FDA inspection called into question the sterility of the products. These products are intended to be sterile, a critical requirement for injectable medications. Assurance of sterility could not be established.
The affected lot numbers include 37-886265, 37-886266, 37-889903, 37-890551, 37-892521, 37-892620, 37-896246, 37-896247, and 37-898553, with expiration dates ranging from May 11, 2023 to June 29, 2023.
The recalled product
- Product
- oxyTOCIN 40 units added to 0.9% sodium chloride 1,000 bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8069-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Intravenous / Admixture
- Affected units
- 2,186
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 (15)
- Lot # 37-886265
- Exp 05/11/2023
- 37-886266
- 37-889903
- Exp 05/25/2023
- 37-890551
- Exp 05/29/2023
- 37-892521
- 37-892620
- Exp 06/06/2023
- 37-896246
- 37-896247
- Exp 06/20/2023
- 37-898553
- Exp 06/29/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 108 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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