FDA Recalls Sermorelin Acetate Injectable Kits Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling Sermorelin Acetate/GHRP (2) 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 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 injectables) are categorized as Severe (Score 4), as they are not Class I (Critical) but represent a significant risk.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Sermorelin Acetate/GHRP (2) Kit 6 mg/4.5 mg Injectable Kits. The product was compounded by Wells Pharmacy Network LLC in Ocala, Florida. The recall covers 176 kits prepared between February 22, 2016, and September 14, 2016, which are within their expiration dates. Specific lot codes for both kits and vials are identified in the recall notice.
The reason for the recall is a lack of assurance of sterility. The FDA has classified this as a Class II recall, 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. The product was distributed nationwide.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. Patients should not discard the product until instructed to do so by a medical professional, as it may be needed for return or disposal verification.
The recalled product
- Product
- Sermorelin Acetate/GHRP (2) Kit 6 mg/4.5 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 176
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: 04062016@170
- 05272016@67
- 09132016@98. Known vial lot code: 03302016@12
- 050412016@84
- 08222016@27.
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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