The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0896-2017·Announced 2017-06-14

Qualgen Estradiol Pellets Recalled for Quality Assurance Deviations

Qualgen is recalling Estradiol 6 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 4,815 pellets distributed nationwide.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a reasonable probability of temporary or medically reversible health consequences. The source text cites CGMP deviations and lack of quality assurance without reporting specific injuries or illnesses, aligning with a Moderate severity rating for a voluntary precautionary recall.

Plain-English summary

Qualgen is recalling Estradiol 6 mg pellets, which are sterile, subcutaneous, prescription-only products. The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations and a lack of quality assurance.

The affected product is available in 1 count, 12 count, and 30 count bottles. The total quantity involved in the recall is 4,815 pellets. The product was distributed nationwide.

The recall includes specific lots with expiration dates ranging from April 2017 to March 2018. Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider or the manufacturer for further instructions.

The recalled product

Product
Estradiol 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.
Manufacturer
Qualgen
Category
Drug — Hormone Pellets
Hazard
Affected units
4,815

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 (10)

  • 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. 04/26/17

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 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 8 products in this recall →

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