The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0893-2017·Announced 2017-06-14

Qualgen Recalls Estradiol Pellets Due to Quality Assurance Deviations

Qualgen is recalling Estradiol 15 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 6,227 units 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, and the source text cites CGMP deviations and lack of quality assurance without reporting specific injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Qualgen is recalling Estradiol 15 mg pellets (NDC: 69761-015-01) in 1, 12, and 30 count bottles. The product is sterile, for subcutaneous use only, and requires a prescription. The recall involves 6,227 pellets distributed nationwide.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations and a lack of quality assurance. Specific affected lots include C028, C005, B142, B114, B099, B069, and B048, with expiration dates ranging from June 2017 to February 2018.

Healthcare providers and patients should stop using the affected products and contact Qualgen for further instructions or a refund.

The recalled product

Product
Estradiol 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
Manufacturer
Qualgen
Category
Drug — Prescription Pellets
Hazard
Affected units
6,227

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 (8)

  • 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. 06/6/17

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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