The Recall Desk
HighFDA (Drugs)·D-0742-2022·Announced 2022-04-13

Drug recall: Papaverine hydrochloride injection due to sterility concerns

Vitae Enim Vitae Scientific, Inc. is recalling papaverine hydrochloride injection nationwide due to manufacturing deviations that compromise sterility assurance in this intravenous drug product.

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: FDA Class II recall involving a sterility defect in an intravenous injectable product. No illnesses or injuries have been reported, making the hazard theoretical rather than confirmed, which limits the score to 3 per the rubric guideline for risk-of-harm products without reported illness.

Plain-English summary

Vitae Enim Vitae Scientific, Inc. is recalling specific lots of papaverine hydrochloride injection, USP 60 mg/2mL, distributed nationwide. The affected product is supplied in two package sizes: 25-vial boxes (NDC 72516-024-25) and 10-vial boxes (NDC 72516-024-10). A total of 2,798 boxes are being recalled.

The recall is due to deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of these products. Because papaverine hydrochloride is intended for intravenous injection, maintaining sterility is critical to patient safety.

Healthcare providers and patients who have received or have in stock the affected lots should not use the product. The affected lot numbers are: 20VPHI037, 20VPHI038, 20VPHI039 (expiration 12/31/2022); 21VPHI021, 21VPHI022, 21VPHI023 (expiration 6/30/2023); 21VPHI047, 21VPHI048 (expiration 10/31/2023) for the 25-vial packages, and 21VPHI023 (expiration 6/30/2023) for the 10-vial packages. Affected product should be returned to Vitae Enim Vitae Scientific, Inc. or discarded according to institutional protocols.

The recalled product

Product
PAPAVERINE HYDROCHLORIDE (PAPAVERINE HYDROCHLORIDE)
Brand
PAPAVERINE HYDROCHLORIDE
Manufacturer
Vitae Enim Vitae Scientific, Inc.
Category
Drug — Injectable
Hazard
  • sterility-defect
  • 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 (12)

  • Lot #: a) 20VPHI037
  • 20VPHI038
  • 20VPHI039
  • Exp 12/31/2022
  • 21VPHI021
  • 21VPHI022
  • 21VPHI023
  • Exp 6/30/2023
  • 21VPHI047
  • 21VPHI048
  • Exp 10/31/2023
  • b) 21VPHI023

Distribution

Distributed nationwide across the United States.

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