The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0654-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

Partell Specialty Pharmacy is recalling Testosterone/Finasteride/Anastrozole pellets because they were sterilized using a non-approved 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 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant risks such as lack of sterility assurance.

Plain-English summary

Partell Specialty Pharmacy is recalling Testosterone/Finasteride/Anastrozole 120 mg/10 mg/4 mg 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 and was distributed in Nevada. The specific lot number is 20180111@104, with a beyond-use date of July 10, 2018.

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

The recalled product

Product
Testosterone/Finasteride/Anastrozole 120 mg/10 mg/4 mg pellet 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#: 20180111@104
  • BUD 07/10/2018.

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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