Vasopressin Injectable Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling vasopressin 40 units injectable because FDA inspection raised concerns about sterility assurance.
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 injectable medication with potential sterility failure. No reported illnesses or injuries have been documented. Per rubric, risk-of-harm products without reported injury are rated High (score 3).
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling vasopressin 40 units in 0.9% sodium chloride injectable solution, distributed nationwide in the United States. The affected lot numbers are 37-889738 and 37-889742, with an expiration date of May 2023. The product is supplied in 100 mL bags at 0.4 units/mL.
The recall was initiated following an FDA inspection that raised questions about the sterility assurance of these products. Vasopressin is a prescription-only injectable medication used in hospital and clinical settings.
The recalled product
- Product
- vasopressin 40 units added to 0.9% sodium chloride 100 mL*, 0.4 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9001-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable
- Hazard
- Affected units
- 100
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 (3)
- Lot # 37-889738
- 37-889742
- Exp 05/25/2023
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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