The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0673-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls Estradiol Pellets Due to Sterility Concerns

Partell Specialty Pharmacy is recalling Estradiol 10 mg pellets in Nevada due to a non-approved sterilization method.

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 3/5 (High).

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 (sterility failure) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Partell Specialty Pharmacy is recalling Estradiol 10 mg (SD) pellets in amber vials. The recall is being conducted because the firm used a non-approved method of sterilization, which raises concerns about the sterility of the product.

The affected product is prescription-only and was distributed in Nevada. Specific lot numbers and expiration dates are listed in the recall documentation. No illnesses or injuries have been reported in the source text.

Consumers who have this product should contact their healthcare provider or the pharmacy for instructions on how to proceed.

The recalled product

Product
Estradiol 10 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.
Manufacturer
Partell Specialty Pharmacy
Category
Drug — Prescription Pellets
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 (12)

  • Lot#: 20171201@84
  • BUD: 05/30/2018
  • 20180125@31
  • BUD 07/24/2018
  • 20180209@106
  • BUD 08/08/2018
  • 20171011@69
  • BUD 04/09/2018
  • 20171019@10
  • BUD 04/17/2018
  • 20171106@103
  • BUD 05/05/2018.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 49 recalled by Partell Specialty Pharmacy 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 49 products in this recall →

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