Agency classClass IIOur severity:Severe FDA (Drugs)·D-0392-2017·Announced 2017-01-11

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.

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. 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: sterility
infection-risk
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.

See all 97 products in this recall →

Same manufacturer · Wells Pharmacy Network LLC

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