The Recall Desk
SevereFDA (Drugs)·D-0414-2017·Announced 2017-01-11

Wells Pharmacy Recalls Trimix Injectable Due to Sterility Concerns

Wells Pharmacy Network LLC is recalling Trimix Injectable vials because the product may lack assurance of sterility.

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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility in an injectable drug corresponds to a severity score of 4 (Severe).

Plain-English summary

Wells Pharmacy Network LLC is recalling specific vials of Trimix Injectable compounded in Ocala, Florida. The recall is being conducted because the product lacks assurance of sterility.

The affected product includes 2 mL, 5 mL, and 10 mL vials of Trimix Injectable (17.65 mg/0.59 mg/5.9 mcg/mL). The recall covers all lot codes for product prepared between February 22, 2016, and September 14, 2016, that are within their expiration date. Specific known lot codes include 07192016@25, 06202016@157, and 05042016@16. The product was distributed nationwide.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Trimix Injectable 17.65 mg/0.59 mg/5.9 mcg/mL a) 2 mL, b) 5 mL and c) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Hazard

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 (1)

  • All lot codes of product prepared between 02/22/2016 and 09/14/2016

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 →