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Drug recall · FDA · Published April 19, 2017

Qualgen recalls Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use

CGMP deviations- Lack of Quality Assurance

🇺🇸 FDA recall #D-0891-2017DrugQualgen ›
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Recalling firmQualgen14844 Bristol Park Blvd, N/A · Edmond, OK 73013-1891
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
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Source Page by GovInfoNow · govinfonow.com/recall/41649-qualgen-recalls-estradiol-20-mg-pellet-99-5-estradiol-usp · Recall date April 19, 2017 · FDA enforcement record: FDA #D-0891-2017

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“Qualgen recalls Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use.” GovInfoNow, recall dated April 19, 2017. https://govinfonow.com/recall/41649-qualgen-recalls-estradiol-20-mg-pellet-99-5-estradiol-usp. Based on FDA recall #D-0891-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0891-2017%22&limit=1).

How to tell if you have this one

  • Brand
    Qualgen
  • Category
    Drug
FDA recall event · 8 products

All 8 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 numberProduct, codes & lotsQuantity
D-0889-2017Estradiol 25 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only. Rx Only ,Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-025-01,; Lot # C031; Exp. 03/2/18 Lot # B077; Exp. 08/10/17 Lot # B040; Exp. 05/16/171,153 pellets.
D-0890-2017Estradiol 22 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF, in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC 69761-022-01; Lot # B128; Exp. 11/1/17 Lot # B075; Exp. 08/3/171,666 pellets.
D-0891-2017Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-020-01; Lot# C022; Exp. 08/21/17 Lot# B143; Exp. 11/22/17 Lot# B104; Exp. 09/27/17 Lot# B073; Exp. 08/1/17 Lot# B052; Exp. 06/13/174,468 pellets.
D-0892-2017Estradiol 18 mg pellet , 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-018-01.; Lot# C018; Exp. 08/2/17 Lot# B151; Exp. 12/7/17 Lot# B108; Exp. 10/3/17 Lot# B095; Exp. 09/12/17 Lot# B062; Exp. 07/6/17 Lot# B035; Exp. 05/2/17 Lot# B133; Exp. 11/4/176,361 pellets.
D-0893-2017Estradiol 15 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles. Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-015-01; Lot# C028; Exp. 02/28/18 Lot# C005; Exp. 07/11/17 Lot# B142; Exp. 11/21/17 Lot# B114; Exp. 10/10/17 Lot# B099; Exp. 09/16/17 Lot# B069; Exp. 07/12/17 Lot# B048; Exp. 06/6/176,227 pellets
D-0894-2017Estradiol 12.5 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only, Rx Only, Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013, NDC: 69761-012-01; Lot# C044; Exp. 03/14/18 Lot# C013; Exp. 07/23/17 Lot# B150; Exp. 12/6/17 Lot# B119; Exp. 10/18/17 Lot# B097; Exp. 09/14/17 Lot# B061; Exp. 07/5/174,883 pellets.
D-0895-2017Estradiol 10 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only , For Subcutaneous Use Only Rx Only Manufactured by: Qualgen 14844 Bristol Park Blvd Edmond, OK 73013 NDC: 69761-010-01; Lot# C021; Exp. 08/20/17 Lot# B160, Exp. 12/29/17 Lot# B140; Exp. 11/15/17 Lot# B107; Exp. 09/29/17 Lot# B079; Exp. 08/15/17 Lot# B046; Exp. 06/01/175,260 pellets.
D-0896-2017Estradiol 6 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count, 12 count, and 30 count bottles, Sterile Office Use Only, For Subcutaneous Use Only Rx Only, Manufactured by; Qualgen 14844 Bristol Park Blvd. Edmond, OK 73013 NDC: 69761-006-01.; Lot# C046; Exp. 03/15/18 Lot# C025; Exp. 08/23/17 Lot# B159; Exp. 12/28/17 Lot# B121; Exp. 10/10/17 Lot# B118; Exp. 10/17/17 Lot# B086; Exp. 08/29/17 Lot# B068; Exp. 07/11/17 Lot# B053; Exp. 06/14/17 Lot# B034; Exp. 04/26/174,815 pellets.
Take action

Contact Qualgen

We’ve drafted a message you can send Qualgen to request your refund or repair — edit it as you like.

✉️ Open in email
Subject: Recall D-0891-2017 — Qualgen Qualgen recalls Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count 

Hello,

I own a Qualgen recalls Estradiol 20 mg pellet 99.5% Estradiol USP, .5% Stearic Acid NF in 1 count and 12 count bottles, Sterile Office Use that is covered by recall D-0891-2017 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.

Similar recalls

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
Qualgen · 91% matchBeacon Hill Medical Pharmacy, P.C. recalls ESTRADIOL CYP/PROG/TEST CYP 0.5/10/10 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX
Beacon Hill Medical Pharmacy, P.C. · 84% matchQualgen, LLC recalls Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx Only Qualgen, LLC,
Qualgen · 83% matchPfizer recalls Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira,
PfizerInventia Healthcare Limited recalls Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC:
Inventia Healthcare Limited

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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-0891-2017 (April 19, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0891-2017 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA