The Recall Desk
Agency classClass IIOur severity: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.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Manufacturer
Wells Pharmacy Network LLC
Category
Drug — Injectable
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 (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 →

Related recalls

Same manufacturer · Wells Pharmacy Network LLC

See all →

Same hazard · sterility

See all →

Similar recalls