The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0652-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

Partell Specialty Pharmacy is recalling specific testosterone and hormone pellet vials 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 and involves a lack of assurance of sterility in drug products, which meets the criteria for a Severe rating due to the potential for significant health risks from non-sterile medication.

Plain-English summary

Partell Specialty Pharmacy is recalling specific vials of testosterone and hormone pellets, including Testosterone/Estradiol, Testosterone/Finasteride, and Testosterone/Finasteride/Anastrozole combinations. The recall is being conducted because the firm used a non-approved method of sterilization for these products, which raises concerns about the assurance of sterility.

The affected products are prescription-only amber vials distributed in Nevada. Specific lot information includes Lot # 20171010@76 with a best-use date of 04/08/2018. The recall is classified as FDA Class II.

Consumers who have these specific products should stop using them and contact their healthcare provider or the pharmacy for further instructions on how to return or dispose of the medication.

The recalled product

Product
Testosterone/Estradiol 60 mg/6 mg pellet Amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800 Testosterone/Finasteride 60 mg/5 mg pellet Amber vial, twist top surrounded by a wrapper Testosterone/Finasteride…
Manufacturer
Partell Specialty Pharmacy
Category
Drug — Prescription Pellets
Hazard
Affected units
1

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#: 20171010@76
  • BUD: 04/08/2018.

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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