The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0657-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls Testosterone Propionate Due to Sterility Concerns

Partell Specialty Pharmacy is recalling Testosterone Propionate 100mg/mL vials 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a drug product, which aligns with the criteria for a Severe rating (FDA Class II with potential for significant harm).

Plain-English summary

Partell Specialty Pharmacy is recalling Testosterone Propionate 100mg/mL, 5 mL 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 product.

The affected product is identified by Lot # 20171228@15 with a beyond-use date of 03/28/2018. The recall is limited to distribution in Nevada (NV only).

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Testosterone Propionate 100mg/mL, 5 mL 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 Steroids
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 (2)

  • Lot #: 20171228@15
  • BUD 03/28/2018

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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