The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0651-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls Testosterone/Anastrozole Pellets Due to Sterility Concerns

Partell Specialty Pharmacy is recalling Testosterone/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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with non-sterile injectable drugs.

Plain-English summary

Partell Specialty Pharmacy is recalling Testosterone/Anastrozole 120 mg/8 mg pellets packaged in amber vials. The recall is due to the use of a non-approved method of sterilization, which raises concerns about the sterility of the drug products.

The affected products are prescription-only and were distributed only in Nevada. The recall covers specific lots identified by the codes 20171220@11 and 20180201@33.

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

The recalled product

Product
Testosterone/Anastrozole 120 mg/8 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 — Injectable Pellets
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 (4)

  • Lot#: 20171220@11
  • BUD 06/18/2018
  • 20180201@33
  • BUD 07/31/2018.

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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