Agency classClass IIOur severity:Severe FDA (Drugs)·D-0410-2017·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 because they may lack assurance of sterility. The recall covers products prepared between February 22, 2016, and September 14, 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving injectable products where sterility failures pose significant health risks.

Plain-English summary

Wells Pharmacy Network LLC is voluntarily recalling Trimix with Atropine Injectable 30 mg/3 mg/300 mcg/0.2 mg/mL, 10 mL vials. The recall is being conducted because the product lacks assurance of sterility. The affected product was compounded by Wells Pharmacy in Ocala, Florida, and distributed nationwide.

The recall includes all lot codes of the product prepared between February 22, 2016, and September 14, 2016, that are within their expiration date. One known lot code is 07192016@8. The product quantity involved is 3 vials.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified 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/300 mcg/0.2 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Manufacturer: Wells Pharmacy Network LLC
Category: Drug — Compounded Injectable
Hazard: lack-of-sterility
infection-risk
Affected units: 3

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: 07192016@8.

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

See all →

Severe
Wells Pharmacy Recalls Injectable Compounds Due to Sterility Concerns
FDA (Drugs) · 2017-01-11
Severe
Wells Pharmacy Recalls Compounded Chorionic Gonadotropin Injectable Kits
FDA (Drugs) · 2017-01-11
Severe
Wells Pharmacy Recalls Compounded Injectable Due to Sterility Concerns
FDA (Drugs) · 2017-01-11
Severe
Wells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns
FDA (Drugs) · 2017-01-11
Severe
Wells Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2017-01-11

Same hazard · lack of sterility