The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1574-2019·Announced 2019-08-07

Wise Pharmacy Recalls Papaverine, Phentolamine, and Alprostadil Injectable Vials

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

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 2/5 (Moderate).

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 situation where use of the product may cause temporary or medically reversible adverse health consequences. The source text does not report any specific injuries or illnesses, aligning with a moderate severity rating for a lack of processing controls.

Plain-English summary

Wise Pharmacy, located in Littleton, Colorado, is recalling 44 vials of Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable, 2.5 mL Vial. The product is prescription-only and was compounded by the pharmacy. The recall is being conducted due to a lack of processing controls.

The affected product includes Lot # 5333N with an expiration date of 7/12/2019, and Lot # 7000N with an expiration date of 10/18/2019. The distribution pattern for these vials includes Colorado, Texas, and Wyoming.

The U.S. Food and Drug Administration has classified this recall as Class II. Consumers and healthcare providers who have these specific vials should stop using them and contact their pharmacist or physician for further instructions.

The recalled product

Product
Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 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
44

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 #: 5333N
  • Exp 7/12/2019
  • 7000N
  • Exp 10/18/2019

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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