The Recall Desk
ModerateFDA (Drugs)·D-1568-2019·Announced 2019-08-07

Wise Pharmacy Recalls Alprostadil Injectable Due to Lack of Processing Controls

Wise Pharmacy is recalling Alprostadil 100 mcg/mL Injectable vials 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 FDA classified this recall as Class II, which typically indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any specific injuries or illnesses, and the hazard is related to processing controls rather than a specific high-risk pathogen or structural defect.

Plain-English summary

Wise Pharmacy, located in Littleton, Colorado, is recalling Alprostadil 100 mcg/mL Injectable, 2.5 mL vials. The recall is being conducted because of a lack of processing controls. The affected product is prescription-only and was compounded by Wise Pharmacy.

The recall involves Lot #6981N, which has an expiration date of 10/17/2019. A total of 4 vials were distributed. The product was distributed to locations in Colorado, Texas, and Wyoming.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions. The U.S. Food and Drug Administration (FDA) has classified this recall as Class II.

The recalled product

Product
Alprostadil 100 mcg/mL Injectable, 2.5 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.
Manufacturer
Wise Pharmacy
Affected units
4

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 #: 6981N
  • Exp 10/17/2019

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 →