The Recall Desk
SevereFDA (Drugs)·D-1577-2019·Announced 2019-08-07

Wise Pharmacy Recalls Compounded Papaverine Injectable Due to Processing Controls

Wise Pharmacy is recalling 14 vials of compounded Papaverine/Phentolamine/Alprostadil/Atropine injectable due to a lack of processing controls.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source identifies this as an FDA Class II recall. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving compounded injectables where processing control failures can lead to significant health risks.

Plain-English summary

Wise Pharmacy, located in Littleton, Colorado, is recalling 14 vials of Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/mL Injectable. The product is a prescription-only compounded medication distributed in Colorado, Texas, and Wyoming. The specific lot number is 6153N, with an expiration date of August 29, 2019.

The recall was initiated due to a lack of processing controls. This FDA Class II recall indicates that the use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences.

Consumers and healthcare providers who have this specific product should stop using it and contact their pharmacist or healthcare provider for instructions on how to return or dispose of the medication.

The recalled product

Product
Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/mL Injectable, 2.5 mL Vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Manufacturer
Wise Pharmacy
Affected units
14

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 (2)

  • Lot #: 6153N
  • Exp8/29/2019

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 →