The Recall Desk
SevereFDA (Drugs)·D-0415-2017·Announced 2017-01-11

Wells Pharmacy Recalls Trimix Injectable Due to Sterility Concerns

Wells Pharmacy Network LLC is recalling Trimix Injectable vials because the agency could not ensure the product was sterile. The recall covers vials prepared between February 2016 and September 2016.

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, which corresponds to a Severe severity score under the rubric. The hazard involves a lack of assurance of sterility in an injectable drug, posing a significant risk of infection.

Plain-English summary

Wells Pharmacy Network LLC is recalling specific vials of Trimix Injectable 30 mg/1 mg/10 mcg/mL. The recall includes 2 mL, 5 mL, and 10 mL vials compounded by Wells Pharmacy in Ocala, Florida. The agency identified a lack of assurance of sterility for these products.

The recall affects vials prepared between February 22, 2016, and September 14, 2016, that are within their expiration dates. Specific lot codes are listed in the recall documentation for the 2 mL, 5 mL, and 10 mL vials. The product was distributed nationwide.

Consumers and healthcare providers should check their inventory for the affected lot codes and stop using the product. They should contact Wells Pharmacy Network LLC for further instructions or to arrange for a return.

The recalled product

Product
Trimix Injectable 30 mg/1 mg/10 mcg/mL a) 2 mL and b) 5 mL and c) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL

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 (6)

  • All lot codes of product prepared between 02/22/2016 and 09/14/2016
  • 05182016@16
  • 09082016@28 c) Known lot code: 04072016@13
  • 05192016@22
  • 06132016@36
  • 08032016@35.

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 →