Wells Pharmacy Recalls Compounded Chorionic Gonadotropin Injectable Kits
Wells Pharmacy Network LLC is recalling compounded Chorionic Gonadotropin injectable kits due to a lack of assurance of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a sterile injectable drug with a lack of assurance of sterility, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Wells Pharmacy Network LLC is voluntarily recalling 1,638 kits of Chorionic Gonadotropin, Lyophilized, 7,500 unit Injectable Kit. The product was compounded by Wells Pharmacy in Ocala, Florida, and distributed nationwide. The recall covers all lot codes of product prepared between February 22, 2016, and September 14, 2016, within their expiry dates.
The recall is being conducted because of a lack of assurance of sterility. The source text does not report any specific illnesses, injuries, or deaths associated with the use of these products.
Consumers who have these products should stop using them and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Chorionic Gonadotropin, Lyophilized, 7,500 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 1,638
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 (11)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known kit lot code:04052016@14
- 05162016@126
- 06092016@173
- 06202016@137
- 08042016@97
- 09132016@117. Known vial lot code: 03242016@31
- 04262016@25
- 06032016@44
- 07252016@56
- 09092016@17.
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.
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