The Recall Desk
SevereFDA (Drugs)·D-0409-2017·Announced 2017-01-11

Wells Pharmacy Recalls Trimix with Atropine Injectable Due to Sterility Concerns

Wells Pharmacy Network LLC is recalling specific lots of Trimix with Atropine Injectable because the agency could not ensure the product was sterile.

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 explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe).

Plain-English summary

Wells Pharmacy Network LLC is voluntarily recalling specific lots of Trimix with Atropine Injectable 30 mg/3 mg/150 mcg/0.2 mg/mL. The recall affects 2 mL, 5 mL, and 10 mL vials compounded by Wells Pharmacy in Ocala, Florida. The product was distributed nationwide.

The recall was initiated due to a lack of assurance of sterility. The affected lots were prepared between February 22, 2016, and September 14, 2016, and are within their expiration dates. Specific lot codes identified in the recall include 04042016@22, 07192016@3, and 04112016@13.

Consumers and healthcare providers should check their inventory for these specific lot codes and stop using the product if it matches the recalled description. The FDA classifies 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
Trimix with Atropine Injectable 30 mg/3 mg/150 mcg/0.2 mg/mL, a) 2 mL b) 5 mL and 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 →