The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0671-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

Partell Specialty Pharmacy is recalling Testosterone/Anastrozole pellets because a non-approved sterilization method was used, raising concerns about sterility assurance.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states the agency classification is Class II. According to the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant risks such as sterility assurance failures in injectable or implantable drugs.

Plain-English summary

Partell Specialty Pharmacy is recalling Testosterone/Anastrozole 60 mg/1 mg pellets packaged in amber vials. The recall was initiated because the firm used a non-approved method of sterilization, which raises concerns about the lack of assurance of sterility for the product.

The affected product is prescription-only and was distributed in Nevada. The specific lot number is 20171130@64, with a beyond-use date of 05/29/2018. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

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

The recalled product

Product
Testosterone/Anastrozole 60 mg/1 mg pellets packaged 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 — Compounded 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 (2)

  • Lot#: 20171130@64
  • BUD 05/29/2018.

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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