The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0892-2018·Announced 2018-07-11

Qualgen Recalls Estradiol Pellets Due to Incorrect or Missing Lot and Expiration Dates

Qualgen, LLC is recalling Estradiol 20mg Pellets because the vials have incorrect or missing lot and expiration dates.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a documentation and labeling error (missing or incorrect lot/expiration dates) rather than a direct safety hazard like contamination or structural defect.

Plain-English summary

Qualgen, LLC is recalling Estradiol 20mg Pellets, 1-count 3ml amber vials, due to labeling errors. The recalled product may have incorrect or missing lot and expiration dates. The affected lots are C211 (expiration date 10/03/2018), C257 (expiration date 12/14/2018), and D001 (expiration date 01/02/19).

The product was distributed nationwide in the USA. The recall involves 2,940 pellets. The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.

Consumers should check their Estradiol 20mg Pellets for the lot numbers and expiration dates listed above. If the product matches the recalled lots, consumers should stop using it and contact their pharmacist or healthcare provider for instructions on how to return the product or obtain a replacement.

The recalled product

Product
ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01
Manufacturer
Qualgen, LLC
Category
Drug — Compounded Prescription
Hazard
Affected units
2,940

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 (2)

  • lot# C211 Exp. date 10/03/2018
  • C257 Exp. date 12/14/2018 and lot # D001 exp. date 01/02/19

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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