Agency classClass IIOur severity:High FDA (Drugs)·D-0382-2017·Announced 2017-01-11

Wells Pharmacy Recalls Nandrolone Decanoate Injectable Due to Sterility Concerns

Wells Pharmacy Network LLC is recalling 526 vials of compounded Nandrolone Decanoate injectable 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II due to a lack of assurance of sterility, which poses a risk of harm (infection) but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Wells Pharmacy Network LLC is voluntarily recalling 526 vials of Nandrolone Decanoate (H), 200 mg/mL Injectable, 10 mL vial. The product was compounded by Wells Pharmacy in Ocala, Florida, and distributed nationwide. The recall covers all lot codes of the product prepared between February 22, 2016, and September 14, 2016, that are within their expiration date. Specific known lot codes include 04112016@16, 04282016@3, 05202016@6, 06132016@4, 07052016@1, and 07272016@7.

The recall was initiated due to a lack of assurance of sterility. The U.S. Food and Drug Administration 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.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product: Nandrolone Decanote (H), 200 mg/mL Injectable, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Manufacturer: Wells Pharmacy Network LLC
Category: Drug — Compounded Injectable
Hazard: sterility
infection-risk
Affected units: 526

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 (7)

All lot codes of product prepared between 02/22/2016 and 09/14/2016
within expiry. Known lot code: 04112016@16
04282016@3
05202016@6
06132016@4
07052016@1
07272016@7.

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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