FDA Recalls Sermorelin Acetate Injectable Kits Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling Sermorelin Acetate 9 mg Injectable Kits nationwide 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, which corresponds to a Severe rating under the rubric for significant injury or property damage reports, or high-risk scenarios without confirmed fatalities.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Sermorelin Acetate 9 mg Injectable Kits compounded by Wells Pharmacy, Ocala, FL. The recall is being conducted by Wells Pharmacy Network LLC because of a lack of assurance of sterility in the product.
The recall affects 629 kits distributed nationwide. The product includes vials with varying quantities per kit based on prescription. The recall covers all lot codes of product prepared between February 22, 2016, and September 14, 2016, that are within their expiry dates. Specific known kit lot codes include 04212016@55 and 06222016@106, while known vial lot codes include 04142016@31 and 06012016@50.
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
- Sermorelin Acetate 9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 629
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 (4)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known kit lot code: 04212016@55
- 06222016@106. Known vial lot code: 04142016@31
- 06012016@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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