The Recall Desk
ModerateFDA (Drugs)·D-1576-2019·Announced 2019-08-07

Wise Pharmacy Recalls Compounded Papaverine/Phentolamine/Alprostadil Injectable Due to Processing Controls

Wise Pharmacy is recalling 32 vials of compounded Papaverine/Phentolamine/Alprostadil injectable due to a lack of processing controls. The product was distributed in Colorado, Texas, and Wyoming.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a risk of temporary or medically reversible adverse health consequences. The source text does not report any specific illnesses, injuries, or deaths, and the hazard is related to processing controls rather than a confirmed high-risk pathogen or structural defect.

Plain-English summary

Wise Pharmacy, located in Littleton, Colorado, is recalling 32 vials of Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable, 2.5 mL Vial. The recall is being conducted due to a lack of processing controls. The affected product is prescription-only and was compounded by Wise Pharmacy.

The recalled product includes two specific lots: Lot #6176N with an expiration date of 8/30/2019, and Lot #7162N with an expiration date of 10/20/2019. The product was distributed in Colorado, Texas, and Wyoming.

Consumers and healthcare providers who have this product should stop using it and contact their pharmacist or physician for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Manufacturer
Wise Pharmacy
Category
Drug — Compounded Injectable
Hazard
Affected units
32

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 (4)

  • Lot #: 6176N
  • Exp 8/30/2019
  • 7162N
  • Exp 10/20/2019

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 11 recalled by Wise Pharmacy 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 11 products in this recall →

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