Wells Pharmacy Recalls Sermorelin Acetate Injectable Kits Due to Sterility Concerns
Wells Pharmacy is recalling 330 Sermorelin Acetate 28 mg 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 FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall with potential for adverse health consequences (such as sterility issues in injectables) corresponds to a score of 4 (Severe), as it is not a Class I recall but involves a significant risk of harm.
Plain-English summary
Wells Pharmacy Network LLC is recalling 330 Sermorelin Acetate 28 mg Injectable Kits. The products were compounded by Wells Pharmacy in Ocala, Florida, and distributed nationwide. The recall involves kits prepared between February 22, 2016, and September 14, 2016, that are within their expiration dates.
The recall was initiated due to a lack of assurance of sterility. Specific lot codes for the kits and vials are identified in the recall notice, including kit codes 05182016@51, 05262016@146, 06212016@76, and 08052016@74, as well as vial codes 04252016@163, 05042016@87, and 07192016@31.
Consumers and healthcare providers should check their inventory for these specific lot codes and stop using the affected products. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Sermorelin Acetate 28 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 330
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 (7)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known kit lot code: 05182016@51
- 05262016@146
- 06212016@76
- 08052016@74. Known vial lot code: 04252016@163
- 05042016@87
- 07192016@31.
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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