Injectable Vasopressin Products Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalled 1,858 bags of injectable vasopressin nationwide due to FDA concerns about sterility assurance. An FDA inspection questioned whether the products meet required sterility standards.
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 involving an injectable medication with unconfirmed sterility assurance. Although no illnesses have been reported, a sterile pharmaceutical product with uncertain sterility is a risk-of-harm product where injury has not yet been reported, warranting a High severity rating.
Plain-English summary
Central Admixture Pharmacy Services, Inc., is recalling 1,858 bags of vasopressin 20 units in 0.9% sodium chloride solution, 0.2 units/mL, 100 mL per bag. The product is distributed nationwide under NDC 71285-9000-1 as a prescription medication.
An FDA inspection raised concerns about the sterility assurance of these products. Vasopressin is an injectable medication intended for sterile use; failure to maintain sterility could result in microbial contamination and serious infection.
The affected lots include 37-886252, 37-886254, 37-889741, 37-889746, 37-891444, 37-893155, 37-893156, and 37-896812, with expiration dates ranging from May 11, 2023 to June 22, 2023.
The recalled product
- Product
- vasopressin 20 units added to 0.9% sodium chloride 100 mL*, 0.2 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9000-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable medication
- Hazard
- contamination-microbial
- infection-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 (13)
- Lot # 37-886252
- 37-886254
- Exp 05/11/2023
- 37-889741
- 37-889746
- Exp 05/25/2023
- 37-891444
- Exp 06/01/2023
- 37-893155
- 37-893156
- Exp 06/08/2023
- 37-896812
- Exp 06/22/2023
Distribution
Distributed nationwide across the United States.
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