Wells Pharmacy Recalls Chorionic Gonadotropin Injectable Kits Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling 5,277 kits of compounded Chorionic Gonadotropin injectable kits nationwide 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 FDA classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving injectable products where sterility is a critical safety factor.
Plain-English summary
Wells Pharmacy Network LLC is recalling 5,277 kits of Chorionic Gonadotropin, Lyophilized, 5,000 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 dates.
The recall was initiated due to a lack of assurance of sterility. 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, or where the probability of serious adverse health consequences is remote.
Consumers who have this product should stop using it 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, 5,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Affected units
- 5,277
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: 04142016@75
- 04252016@52
- 05042016@143
- 05042016@158
- 06092016@169
- 06242016@158
- 08022016@154
- 08112016@56
- 08252016@82
- 09082016@41. Known vial lot code: 04062016@7
- 04182016@49
- 04292016@80
- 04282016@43
- 06012016@44
- 06152016@57
- 07132016@68
- 08042016@35
- 08192016@45
- 08242016@33
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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