The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0394-2017·Announced 2017-01-11

Wells Pharmacy Recalls Sermorelin Acetate Injectable Kits Due to Sterility Concerns

Wells Pharmacy Network LLC is recalling Sermorelin Acetate/GHRP (2) 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. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility in injectable drugs) are categorized as Severe.

Plain-English summary

Wells Pharmacy Network LLC is recalling Sermorelin Acetate/GHRP (2) 3 mg/4.5 mg Injectable Kits compounded in Ocala, Florida. The recall was initiated because the company could not provide assurance that the products were sterile. The affected products were distributed nationwide.

The recall includes all lot codes of the product prepared between February 22, 2016, and September 14, 2016, that are within their expiration dates. Specific known lot codes include kit lot code 05272016@100 and vial lot code 05042016@94. Each kit contains three kits, though the number of vials per kit varies by prescription.

Consumers who have these products should stop using them and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication. 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/GHRP (2) 3 mg/4.5 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Manufacturer
Wells Pharmacy Network LLC
Category
Drug — Compounded Injectable
Hazard
Affected units
3

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 (1)

  • All lot codes of product prepared between 02/22/2016 and 09/14/2016

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 →

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