The Recall Desk
HighFDA (Drugs)·D-0386-2016·Announced 2015-12-02

Qualgen Recalls Estradiol Pellets Due to Sterility Assurance Concerns

Qualgen is recalling 4,221 vials of compounded Estradiol USP pellets nationwide because deficient practices may have impacted sterility assurance.

What this means for you

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 involves a risk-of-harm product (sterile medication) where injury has not yet been reported, which aligns with the High severity criteria for theoretical hazards without confirmed illness.

Plain-English summary

Qualgen is voluntarily recalling 4,221 vials of Estradiol USP 99.5%, .5% Stearic Acid NF Pellets. The affected product is available in 3 mL one-count vials in various strengths, including 6 mg, 10 mg, 12.5 mg, 15 mg, 18 mg, 20 mg, 22 mg, and 25 mg. The medication is compounded by Qualgen in Edmond, Oklahoma, and was distributed nationwide.

The recall was initiated due to a lack of assurance of sterility. The firm identified deficient practices that may have an impact on sterility assurance for all sterile preparations within their expiry dates. The recall covers specific lots with expiration dates ranging from October 23, 2015, to December 28, 2015.

Consumers and healthcare providers should stop using the affected vials and contact their pharmacist or Qualgen for further instructions or a replacement. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
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
Manufacturer
Qualgen
Category
Drug — Compounded Sterile Preparation
Hazard
Affected units
4,221

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 (19)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Qualgen 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 2 products in this recall →

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