Vasopressin Injectable Drug Recalled Due to Sterility Assurance Questions
FDA recalls 4259 bags of vasopressin injectable solution nationwide due to lack of assurance of sterility following an FDA inspection. The affected lots are intended for central pharmacy use.
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 of an injectable pharmaceutical for which sterility assurance could not be confirmed. While no illnesses or injuries have been reported, the lack of sterility in an injectable medication poses a theoretical risk of serious infection. This meets the 'High' severity threshold for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 4259 bags of vasopressin 50 units in 0.9% sodium chloride injectable solution (1 unit/mL, 50 mL in a 100 mL Partial Additive Bag) that were distributed nationwide in the USA. This product is intended for use in healthcare settings.
The FDA determined that the sterility of these products could not be assured following an inspection. The affected lot numbers have expiration dates ranging from April 30, 2023 to June 25, 2023.
Healthcare facilities that received this product should remove the affected lots from use immediately and verify their inventory against the recalled lot numbers. Concerns or inquiries should be directed to the manufacturer, Central Admixture Pharmacy Services, Inc.
The recalled product
- Product
- vasopressin 50 units added to 0.9% sodium chloride 50 mL*, 1 unit/mL*, 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9002-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Category
- Drug — Injectable / Sterility
- Hazard
- lack-of-sterility
- microbial-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 # 37-883209
- 37-883211
- 37-883212
- 37-883214
- 37-883215
- Exp 04/30/2023
- 37-883776
- Exp 05/02/2023
- 37-884451
- Exp 05/04/2023
- 37-884805
- 37-884806
- 37-884808
- 37-884810
- 37-884811
- Exp 05/07/2023
- 37-886498
- 37-886506
- 37-886507
- 37-886509
Distribution
Distributed nationwide across the United States.
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