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.
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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility in an injectable drug corresponds to a severity score of 4 (Severe).
Plain-English summary
Wells Pharmacy Network LLC is recalling 18 kits of compounded Chorionic Gonadotropin (New York State), 11,000 unit Injectable Kit. The product was compounded by Wells Pharmacy in Ocala, Florida, and distributed nationwide. The recall is being conducted due to a lack of assurance of sterility.
The affected product includes all lot codes prepared between February 22, 2016, and September 14, 2016, that are within their expiry date. Specific known kit lot codes include 06072016@44, 07292016@92, 08092016@80, and 09132016@33. Known vial lot codes include 04042016@30, 07222016@26, and 08252016@3.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Chorionic Gonadotropin (New York State), 11,000 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 18
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 (8)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known kit lot code: 06072016@44
- 07292016@92
- 08092016@80
- 09132016@33. Known vial lot code: 04042016@30
- 07222016@26
- 04042016@30
- 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.
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