The Recall Desk
SevereFDA (Drugs)·D-0678-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls Estradiol Pellets Due to Sterility Concerns

Partell Specialty Pharmacy is recalling Estradiol 35 mg pellets in Nevada due to the use of 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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection from lack of sterility assurance.

Plain-English summary

Partell Specialty Pharmacy is recalling Estradiol 35 mg (SD) pellets in amber vials. The recall is being conducted because the firm used a non-approved method of sterilization for these drug products.

The affected product is prescription-only Estradiol 35 mg (SD) pellets. The specific lot number is #20171102@42, with a beyond-use date of 05/01/2018. The distribution was limited to Nevada.

Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.

The recalled product

Product
Estradiol 35 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800.

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 (2)

  • Lot: #20171102@42
  • BUD 05/01/2018.

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 →