Wells Pharmacy Recalls Compounded Chorionic Gonadotropin Injectable Kits
Wells Pharmacy Network LLC is recalling 908 compounded Chorionic Gonadotropin Injectable Kits nationwide 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 risk-of-harm product (sterility issue in an injectable drug) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Wells Pharmacy Network LLC is recalling 908 kits of Chorionic Gonadotropin Lyophilized, 20,000 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, that are within their expiry date.
The recall was initiated due to 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. Known kit lot codes include 04212016@42, 06092016@164, and 08122016@96. Known vial lot codes include 04132016@96, 05242016@1, and 08082016@50.
Consumers and healthcare providers should check their inventory for these specific lot codes and stop using the product if it matches the recalled description. Patients who have already used the product should consult their healthcare provider for guidance.
The recalled product
- Product
- Chorionic Gonadotropin Lyophilized, 20,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 908
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:04212016@42
- 06092016@164
- 08122016@96. Known vial lot code: 04132016@96
- 05242016@1
- 08082016@50.
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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