Agency classClass IIOur severity:Severe FDA (Drugs)·D-0356-2017·Announced 2017-01-11

Wells Pharmacy Recalls Fluorescein/Indocyanine Injectable Kits Due to Sterility Concerns

Wells Pharmacy Network LLC is recalling 203 kits of compounded Fluorescein/Indocyanine Injectable Kits nationwide due to a lack of assurance of sterility.

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 source text identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving injectable products where sterility assurance is compromised.

Plain-English summary

Wells Pharmacy Network LLC is voluntarily recalling 203 kits of Fluorescein/Indocyanine, Lyophilized (P.F.), 400 mg/15 mg, 1 mL, Injectable Kit. The product was compounded by Wells Pharmacy in Ocala, Florida, and distributed nationwide. The recall is being conducted due to a lack of assurance of sterility.

The affected product includes all lot codes prepared between February 22, 2016, and September 14, 2016, that are within their expiry date. Specific known lot codes include kit code 06082016@133 and vial code 05202016@4. The number of vials per kit varies by prescription.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for instructions on return or replacement. The FDA has classified this recall as Class II, indicating that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product: Fluorescein/Indocyanine, Lyophilized (P.F.), 400 mg/15 mg, 1 mL, Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Manufacturer: Wells Pharmacy Network LLC
Category: Drug — Compounded Injectable
Hazard: sterility
infection
Affected units: 203

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 →

Same manufacturer · Wells Pharmacy Network LLC

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