The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0749-2023·Announced 2023-05-31

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.

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: 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
Affected units
4,259

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.

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.

See all 108 products in this recall →

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Same manufacturer · Central Admixture Pharmacy Services, Inc.

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