The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0386-2017·Announced 2017-01-11

FDA Recalls Sermorelin Acetate Injectable Kits Due to Sterility Concerns

Wells Pharmacy is recalling 568 Sermorelin Acetate 15 mg 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, which corresponds to a 'Severe' rating under the rubric for significant injury or property-damage reports or high-risk scenarios.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Sermorelin Acetate 15 mg Injectable Kits compounded by Wells Pharmacy in Ocala, Florida. The recall involves 568 kits distributed nationwide. The specific reason for the recall is a lack of assurance of sterility.

The affected products were prepared between February 22, 2016, and September 14, 2016, and are within their expiry dates. Specific lot codes for the kits and vials are listed in the recall documentation, including kit lot codes 05182016@173, 07052016@148, and 09062016@114, and vial lot codes 04252016@165, 06102016@56, and 08262016@42.

Consumers who have these products should stop using them and contact their healthcare provider or the recalling firm, Wells Pharmacy Network LLC, for further instructions.

The recalled product

Product
Sermorelin Acetate 15 mg Injectable Kit., Compounded by Wells Pharmacy, Ocala, FL
Manufacturer
Wells Pharmacy Network LLC
Category
Drug — Injectable
Hazard
Affected units
568

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: 05182016@173
  • 07052016@148
  • 09062016@114. Known vial lot code: 04252016@165
  • 06102016@56
  • 08262016@42.

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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