Wells Pharmacy Recalls Sermorelin Acetate Injectable Kits Due to Sterility Concerns
Wells Pharmacy Network LLC is recalling Sermorelin Acetate/GHRP (6) Injectable Kits because the agency could not ensure the products were sterile.
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 severity score under the rubric for drug recalls involving potential serious health consequences.
Plain-English summary
Wells Pharmacy Network LLC is recalling Sermorelin Acetate/GHRP (6) 6 mg/3 mg Injectable Kits compounded in Ocala, Florida. The recall was initiated due to a lack of assurance of sterility for the affected products.
The recall covers 1,232 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 documentation. The products were distributed nationwide.
Consumers who possess these specific injectable kits should stop using them and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- Sermorelin Acetate/GHRP (6) 6 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
- Manufacturer
- Wells Pharmacy Network LLC
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 1,232
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 (12)
- All lot codes of product prepared between 02/22/2016 and 09/14/2016
- within expiry. Known kit lot code: 04192016@24
- 05172016@229
- 06032016@136
- 06222016@121
- 06222016@148
- 09132016@102. Known vial lot code: 03242016@27
- 04202016@7
- 05162016@141
- 06032016@47
- 05312016@53
- 08222016@54.
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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