The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0225-2019·Announced 2018-11-14

Qualgen Recalls Estradiol Pellets Due to Lack of Sterility Assurance

Qualgen, LLC is recalling Estradiol 10mg pellets nationwide due to a lack of assurance of sterility. The affected lots have specific expiration dates.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class II recall. Under the rubric, FDA Class II recalls involving significant risks such as sterility issues in injectable/implantable drugs are categorized as Severe.

Plain-English summary

Qualgen, LLC is voluntarily recalling Estradiol 10mg pellets in 1, 6, 12, and 30 count vials. The recall is being conducted because of a lack of assurance of sterility for the product. The affected lots are C262 (expiration 12/20/2018), D067 (expiration 03/21/2019), and D072 (expiration 03/28/2019).

The recall covers distribution nationwide. The product is prescription-only. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the use of these pellets.

Consumers and healthcare providers should stop using the affected Estradiol pellets and contact their healthcare provider for further instructions or to obtain a replacement product.

The recalled product

Product
Estradiol 10mg pellet, 1 count (NDC 69761-010-01), 6 count (NDC 69761-010-06), 12 count (NDC 69761-010-12), and 30 count (NDC 69761-010-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
Manufacturer
Qualgen, LLC
Category
Drug — Prescription Drug
Hazard

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 (4)

  • Lots
  • C262 BUD: 12/20/2018
  • D067 BUD: 03/21/2019
  • D072 BUD: 03/28/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 recalled by Qualgen, 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 14 products in this recall →

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