Agency classClass IIOur severity:Severe FDA (Drugs)·D-0411-2017·Announced 2017-01-11

Wells Pharmacy Recalls Trimix with Atropine Injectable Due to Sterility Concerns

Wells Pharmacy Network LLC is recalling Trimix with Atropine Injectable vials due to a lack of assurance of sterility. The recall covers products 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. 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 voluntarily recalling Trimix with Atropine Injectable 30 mg/3 mg/60 mcg/0.2 mg/mL, 10 mL vials. The recall is being conducted because of a lack of assurance of sterility in the compounded product.

The affected products were prepared by Wells Pharmacy in Ocala, Florida, between February 22, 2016, and September 14, 2016. The recall includes all lot codes of the product prepared within this timeframe that are within their expiration date. One known lot code is 04112016@6. The product was distributed nationwide.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.

The recalled product

Product: Trimix with Atropine Injectable 30 mg/3 mg/60 mcg/0.2 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Manufacturer: Wells Pharmacy Network LLC
Category: Drug — Compounded Injectable
Hazard: sterility
infection
Affected units: 1

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 (2)

All lot codes of product prepared between 02/22/2016 and 09/14/2016
within expiry. Known lot code: 04112016@6.

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 →

Same manufacturer · Wells Pharmacy Network LLC

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