FDA Recalls Sermorelin Acetate Injectable Kits Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling Sermorelin Acetate/GHRP 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, which corresponds to a Severe severity score under the rubric for significant injury risks or hospitalization reports, even if specific injury counts are not detailed in the provided text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Sermorelin Acetate/GHRP (2) & (6) 9 mg/9 mg/9 mg Injectable Kits compounded by Wells Pharmacy, Ocala, FL. The recall is being conducted by Wells Pharmacy Network LLC and affects 1,319 kits distributed nationwide. The specific reason for the recall is a lack of assurance of sterility.
The affected products include all lot codes prepared between February 22, 2016, and September 14, 2016, that are within their expiry dates. Known kit lot codes include 04072016@19, 05272016@55, 06102016@62, and 09062016@75. Known vial lot codes include 03302016@11, 050412016@98, 05172016@10, and 08252016@18. The number of vials per kit varies by prescription.
Consumers and healthcare providers should check their inventory for these specific lot codes. If you have this product, you should stop using it and contact your healthcare provider or the recalling firm for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Sermorelin Acetate/GHRP (2) & (6) 9 mg/9 mg/9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 1,319
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: 04072016@19
- 05272016@55
- 06102016@62
- 09062016@75. Known vial lot code: 03302016@11
- 050412016@98
- 05172016@10
- 08252016@18.
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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