Qualgen recalls Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (NDC 69761-006-01),10 mg (NDC
Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance.
Recall notice
Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance.
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Source Page by GovInfoNow · govinfonow.com/recall/43580-qualgen-recalls-estradiol-usp-99-5-5-stearic-acid-nf · Recall date October 9, 2015 · FDA enforcement record: FDA #D-0386-2016
Cite this page
“Qualgen recalls Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (NDC 69761-006-01),10 mg (NDC.” GovInfoNow, recall dated October 9, 2015. https://govinfonow.com/recall/43580-qualgen-recalls-estradiol-usp-99-5-5-stearic-acid-nf. Based on FDA recall #D-0386-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0386-2016%22&limit=1).
How to tell if you have this one
- Brand
Qualgen- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0386-2016 | Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (NDC 69761-006-01),10 mg (NDC 69761-010-01),12.5 mg (NDC 69761-012-01), 15 mg (NDC 69761-015-01),18 mg (NDC 69761-018-01),20 mg (NDC 69761-020-01), 22 mg (NDC 69761-022-01), 25 mg (NDC 69761-025-01), Rx only, Compounded by Qualgen, Edmond, Oklahoma 73013; Lots: A002 Exp.: 10/23/2015; A003 Exp.: 10/25/2015; A009 Exp.: 11/01/2015; A011 Exp.: 11/2/2015; A014 Exp.: 11/8/2015; A016 Exp.: 11/10/2015; A027 Exp.: 11/20/2015; A028 Exp.: 11/21/2015; A030 Exp.: 11/22/2015; A032 Exp.: 11/23/2015; A037 Exp.: 11/24/2015; A039 Exp.: 11/27/2015; A042 Exp.: 11/28/2015; A044 Exp.: 11/29/2015; A050 Exp.: 12/06/2015; A051 Exp.: 12/10/2015; A053 Exp.: 12/12/2015; A062 Exp.: 12/20/2015; A065 Exp.: 12/28/2015 | 4,221 vials |
| D-0387-2016 | Testosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 25 mg (NDC 69761-125-01), 37.5 mg (NDC 69761-137-01), 50 mg (NDC 69761-150-01), 87.5 mg (NDC: 69761-187-01), 100 mg (NDC 69761-110-01), 200 mg (NDC 69761-120-01), Rx only, Compounded by Qualgen, Edmond, Oklahoma 73013; Lots: A005 Ex.: 10/30/2015; A008 Ex.: 11/01/2015; A010 Ex.: 11/06/2015; A012 Ex.: 11/07/2015; A015 Ex.: 11/08/2015; A018 Ex.: 11/13/2015; A022 Ex.: 11/14/2015; A024 Ex.: 11/16/2015; A026 Ex.: 11/20/2015; A029 Ex.: 11/21/2015; A033 Ex.: 11/23/2015; A038 Ex.: 11/24/2015; A040 Ex.: 11/27/2015; A041 Ex.: 11/28/2015; A045 Ex.: 12/03/2015; A046 Ex.: 11/30/2015; A047 Ex.: 12/04/2015; A052 Ex.: 12/12/2015; A055 Ex.: 12/13/2015; A058 Ex.: 12/18/2015; A059 Ex.: 12/19/2015; A061 Ex.: 12/24/2015 | 10,885 vials |
Contact Qualgen
We’ve drafted a message you can send Qualgen to request your refund or repair — edit it as you like.
Subject: Recall D-0386-2016 — Qualgen Qualgen recalls Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 Hello, I own a Qualgen recalls Estradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (NDC 69761-006-01),10 mg (NDC that is covered by recall D-0386-2016 from Qualgen. 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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Where this comes from
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.
- Official source: FDA Recall #D-0386-2016 (October 9, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0386-2016 to see it in context.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.