The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0682-2018·Announced 2018-04-25

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

Partell Specialty Pharmacy is recalling Testosterone/Finasteride 80 mg/8 mg pellets because a non-approved method of sterilization was used.

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. According to the rubric, FDA Class II recalls with potential for serious injury or hospitalization (implied by lack of sterility assurance in injectable/implantable drugs) map to a score of 4 (Severe).

Plain-English summary

Partell Specialty Pharmacy is recalling Testosterone/Finasteride 80 mg/8 mg pellets, amber vial, Rx only. The recall is being conducted because the firm used a non-approved method of sterilization for these drug products, resulting in a lack of assurance of sterility.

The affected products were distributed only in Nevada. Specific lot codes and best-use dates are listed in the recall documentation, including codes 20180110@57, 20180110@23, 20171003@91, and 20171016@24.

Consumers who have these products should stop using them and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Testosterone/Finasteride 80 mg/8 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/Implantable
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 (6)

  • 20180110@57
  • 20180110@23 BUD 07/09/2018
  • 20171003@91
  • BUD 04/01/2018
  • 20171016@24
  • BUD 04/14/2018.

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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