The Recall Desk
SevereFDA (Drugs)·D-0675-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls Estradiol Pellets Due to Sterility Concerns

Partell Specialty Pharmacy is recalling Estradiol 15 mg pellets in Nevada due to a non-approved sterilization method.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are Severe. While no specific injuries are reported here, the 'lack of assurance of sterility' in a drug product represents a significant potential hazard consistent with the Severe classification for Class II recalls involving critical quality failures.

Plain-English summary

Partell Specialty Pharmacy is recalling Estradiol 15 mg (SD) pellets in amber vials. The recall is being conducted because the firm used a non-approved method of sterilization, resulting in a lack of assurance of sterility for the product.

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

Consumers who have this product should contact their healthcare provider or pharmacist for guidance on how to proceed.

The recalled product

Product
Estradiol 15 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 Medication
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 (6)

  • Lot#: 20171204@117
  • BUD 06/02/2018
  • 20180129@14
  • BUD 07/28/2018
  • 20171011@111
  • BUD 04/09/2018.

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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Same hazard · sterility

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