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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- 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.
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