The Recall Desk
SevereFDA (Drugs)·D-0676-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls Estradiol Pellets Due to Sterility Concerns

Partell Specialty Pharmacy is recalling Estradiol 20 mg pellets in Nevada because a non-approved sterilization method was used.

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. According to the rubric, FDA Class II recalls involving significant risks such as sterility issues in injectable or implantable drugs are categorized as Severe.

Plain-English summary

Partell Specialty Pharmacy is recalling Estradiol 20 mg (SD) pellets in amber vials. The recall is due to a lack of assurance of sterility, as the firm used a non-approved method of sterilization for these drug products.

The affected products are prescription-only and were distributed in Nevada. Specific lot numbers and expiration dates are listed in the recall documentation, including lots with expiration dates ranging from April 2018 to July 2018.

Consumers who have these products should stop using them and contact their healthcare provider or the pharmacy for further instructions.

The recalled product

Product
Estradiol 20 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 Sterile Drug
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 (14)

  • Lot#: 20180129@15
  • BUD 07/28/2018
  • 20171207@83
  • BUD 06/05/2018
  • 20171016@27
  • BUD 04/14/2018
  • 20171204@15
  • BUD 06/02/2018
  • 20171006@57
  • BUD 04/04/2018
  • 20171018@62
  • BUD 04/16/2018
  • 20180116@24
  • BUD 07/15/2018.

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 →

Related recalls

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Same hazard · sterility

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