The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0347-2017·Announced 2017-01-11

Wells Pharmacy Recalls Chorionic Gonadotropin Injectable Kits Due to Sterility Concerns

Wells Pharmacy Network LLC is recalling 1,753 kits of compounded Chorionic Gonadotropin 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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall involving a significant risk such as lack of sterility in an injectable product is categorized as Severe (Score 4), as it carries a reasonable probability of adverse health consequences.

Plain-English summary

Wells Pharmacy Network LLC is voluntarily recalling 1,753 kits of Chorionic Gonadotropin, Lyophilized, 3,500 unit Injectable Kit. The product was compounded by Wells Pharmacy in Ocala, Florida, and distributed nationwide. The recall is being conducted because of a lack of assurance of sterility.

The recall includes all lot codes of the product prepared between February 22, 2016, and September 14, 2016, that are within their expiry dates. Specific known kit lot codes include 04212016@46, 05232016@215, 05232016@216, 07052016@89, 08042016@103, and 09132016@116. Known vial lot codes include 04132016@91, 05162016@136, 06242016@96, 07282016@51, and 09092016@20.

The U.S. Food and Drug Administration has classified this recall as Class II, which means there is a reasonable probability that the use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences. Consumers and healthcare providers should check their inventory for these specific lot codes and stop using the affected kits.

The recalled product

Product
Chorionic Gonadotropin, Lyophilized, 3,500 unit Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Manufacturer
Wells Pharmacy Network LLC
Category
Drug — Compounded Injectable
Hazard
Affected units
1,753

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 (11)

  • All lot codes of product prepared between 02/22/2016 and 09/14/2016
  • within expiry. Known kit lot code: 04212016@46
  • 05232016@215
  • 05232016@216
  • 07052016@89
  • 08042016@103
  • 09132016@116. Known vial lot code: 04132016@91
  • 05162016@136
  • 06242016@96
  • 07282016@51
  • 09092016@20

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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