Agency classClass IIOur severity:Severe FDA (Drugs)·D-0336-2017·Announced 2017-01-11

FDA Recalls Compounded HCG Injectable Kits Due to Sterility Concerns

Wells Pharmacy Network LLC is recalling 10 kits of compounded Chorionic Gonadotropin (HCG) 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 source text identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving sterility issues in injectable products which carry significant injury risks.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for 10 kits of Chorionic Gonadotropin, Lyophilized (HCG) 11,000 Unit Injectable Kit. The product was compounded by Wells Pharmacy, Ocala, FL, and distributed nationwide. The recall is being conducted by Wells Pharmacy Network LLC.

The reason for the recall is a lack of assurance of sterility. The affected products include all lot codes prepared between February 22, 2016, and September 14, 2016, that are within their expiry dates. Specific known kit and vial lot codes are listed in the official recall documentation.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Chorionic Gonadotropin, Lyophilized (HCG) 11,000 Unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Manufacturer: Wells Pharmacy Network LLC
Category: Drug — Compounded Injectable
Hazard: sterility
infection
Affected units: 10

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 (20)

All lot codes of product prepared between 02/22/2016 and 09/14/2016
within expiry. Known kit lot code: 04052016@16
04072016@26
04142016@65
05172016@105
06062016@137
06152016@28
06232016@61
07272016@56
08192016@108
09062016@127 Known vial lot code: 03252016@6
03312016@1
04042016@30
05052016@134
05092016@57
06072016@32
06172016@120
07222016@26
08122016@3
08252016@3.

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 →

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Same hazard · sterility