The Recall Desk
SevereFDA (Drugs)·D-0653-2018·Announced 2018-04-25

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

Partell Specialty Pharmacy is recalling Testosterone/Finasteride pellets because they were sterilized using a non-approved 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 and involves a lack of assurance of sterility, which poses a risk of serious infection or injury, meeting the criteria for a Severe rating.

Plain-English summary

Partell Specialty Pharmacy is recalling specific lots of Testosterone/Finasteride 60 mg/5 mg pellets. 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 product is an amber vial containing 7 vials, distributed only in Nevada. The recall includes lots with the following identifiers and best-by dates: 20171012@63 (BUD 04/10/2018), 20171127@103 (BUD 05/26/2018), and 20180115@69 (BUD 07/14/2018).

Consumers who have this product should contact their healthcare provider or the pharmacy for instructions on how to dispose of or return the medication. The FDA has classified this recall as Class II, indicating that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product
Testosterone/Finasteride 60 mg/5 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 — Injectable Pellets
Hazard
Affected units
7

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 (6)

  • Lot#: 20171012@63
  • BUD 04/10/2018
  • 20171127@103
  • BUD 05/26/2018
  • 20180115@69
  • BUD 07/14/2018.

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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Same hazard · sterility

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