Fagron recalls 1 kg Nandrolone Decanoate (Rx only) due to subpotent drug risk. This affects prescription compounding products with specific NDC and lot numbers.
Subpotent Drug
Fagron is recalling a prescription-only nandrolone decanoate product for compounding due to a subpotent drug issue. This means the medication may not be as effective as intended, which could affect treatment outcomes.
The product is labeled as subpotent, meaning it contains less active drug than specified. This could lead to reduced effectiveness in treating the intended medical condition. However, the recall does not indicate a risk of injury or harm to users.
Prescription compounding pharmacies and healthcare providers who have the specific NDC 0395-8212-43 lot 18L12-U02-050019 product. Patients using this medication under a doctor's supervision are not directly affected by the recall.
Check for the NDC code 0395-8212-43 and lot number 18L12-U02-050019 on the plastic container. This product was distributed by Humco and sold with an expiration date of October 31, 2022.
Verify the NDC code 0395-8212-43 and lot number 18L12-U02-050019 on the plastic container.
The recall indicates the product is subpotent, meaning it may not be as effective as intended. However, it does not pose a risk of injury or harm to users.
The recall does not specify a remedy, so no action is required beyond checking the product details.
Look for the NDC code 0395-8212-43 and lot number 18L12-U02-050019 on the plastic container.
We’ve drafted a message you can send Fagron to request your refund or repair — edit it as you like.
Subject: Recall D-0866-2022 — Fagron Fagron Hello, I own a Fagron that is covered by recall D-0866-2022 from Fagron. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
