The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0670-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls Testosterone and Anastrozole Pellets for Sterility Concerns

Partell Specialty Pharmacy is recalling specific lots of Testosterone/Anastrozole pellets in Nevada due to a non-approved sterilization 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 severity score under the rubric for drug recalls involving potential health risks.

Plain-English summary

Partell Specialty Pharmacy is recalling specific lots of Testosterone/Anastrozole 200 mg/20 mg pellets packaged 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. The recall includes specific lot numbers with expiration dates ranging from April 2018 to August 2018. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the affected products.

The recalled product

Product
Testosterone/Anastrozole 200 mg/20 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 Products
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 (12)

  • Lot#: 20171116@3
  • BUD 05/15/2018
  • 20180221@72
  • BUD
  • 08/20/2018
  • 20171130@79
  • BUD 05/29/2018
  • BUD 08/20/2018
  • 20180206@115
  • BUD 08/05/2018
  • 20171023@98
  • BUD 04/21/2018.

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

Same manufacturer · Partell Specialty Pharmacy

See all →

Same hazard · sterility failure

See all →

Similar recalls