The Recall Desk
SevereFDA (Drugs)·D-0334-2017·Announced 2017-01-11

Wells Pharmacy Recalls Ultra-Test Injectable Due to Sterility Concerns

Wells Pharmacy Network LLC is recalling 714 vials of Ultra-Test in Grapeseed Oil Injectable due to a lack of assurance of sterility. The product was distributed nationwide.

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 text identifies the recall as FDA Class II. According to the rubric, an FDA Class II recall is classified as Severe (Score 4), particularly when involving sterility issues in injectable products which carry significant risk of infection or injury.

Plain-English summary

Wells Pharmacy Network LLC is voluntarily recalling 714 vials of ULTRA-TEST in Grapeseed Oil (CYP 90%/PROP 10%) Injectable, 200 mg/mL, 8 mL vial. The recall is being conducted because of a lack of assurance of sterility in the product.

The affected product was compounded by Wells Pharmacy in Ocala, FL, and distributed nationwide. The recall includes all lot codes of product prepared between February 22, 2016, and September 14, 2016, that are within their expiry date. Specific known lot codes include 03302016@5, 04202016@2, 05172016@5, 06082016@44, 06102016@6, and 08042016@14.

Consumers and healthcare providers should stop using the product and contact Wells Pharmacy Network LLC for further instructions or a refund. 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
ULTRA-TEST in Grapeseed Oil (CYP 90%/PROP 10%) Injectable, 200 mg/mL, 8 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Affected units
714

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 (7)

  • All lot codes of product prepared between 02/22/2016 and 09/14/2016
  • within expiry. Known lot code: 03302016@5
  • 04202016@2
  • 05172016@5
  • 06082016@44
  • 06102016@6
  • 08042016@14

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 97 recalled by Wells Pharmacy Network LLC 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 97 products in this recall →