Wells Pharmacy Recalls Sermorelin Injectable Kits Due to Sterility Concerns
Wells Pharmacy is recalling Sermorelin Acetate/GHRP (2) Injectable Kits because the agency could not ensure the product was sterile.
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 drug recalls involving potential serious health consequences.
Plain-English summary
Wells Pharmacy Network LLC is recalling 158 kits of Sermorelin Acetate/GHRP (2) 9 mg/9 mg Injectable Kit. The recall was initiated due to a lack of assurance of sterility for the compounded product. The kits were distributed nationwide.
The recall includes all lot codes of product prepared between February 22, 2016, and September 14, 2016, that are within their expiration dates. Specific known lot codes include kit codes 05182016@215 and 09062016@92, and vial codes 04252016@158 and 082612016@45.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Sermorelin Acetate/GHRP (2) 9 mg/9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 158
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: 05182016@215
- 09062016@92. Known vial lot code: 04252016@158
- 082612016@45.
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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