Agency classClass IIOur severity:Severe FDA (Drugs)·D-0352-2017·Announced 2017-01-11

Wells Pharmacy Recalls Compounded Chorionic Gonadotropin Injectable Kits

Wells Pharmacy Network LLC is recalling compounded Chorionic Gonadotropin+B12(C) Injectable Kits 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are categorized as Severe.

Plain-English summary

Wells Pharmacy Network LLC is voluntarily recalling 724 kits of Chorionic Gonadotropin+B12(C), Lyophilized, 10,000 unit + 40 mcg Injectable Kit. The recall is being conducted because of a lack of assurance of sterility in the product.

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 expiry date. Specific known kit lot codes include 05042016@162, 06062016@122, and 08192016@110. Known vial lot codes include 04252016@168, 05252016@117, and 08152016@40.

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 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: Chorionic Gonadotropin+B12(C), Lyophilized, 10,000 unit + 40 mcg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Manufacturer: Wells Pharmacy Network LLC
Category: Drug — Compounded Injectable
Hazard: sterility
infection
Affected units: 724

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
within expiry. Known kit lot code: 05042016@162
06062016@122
08192016@110. Known vial lot code: 04252016@168
05252016@117
08152016@40.

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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Same hazard · sterility