The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0663-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls Testosterone Pellets Due to Sterility Concerns

Partell Specialty Pharmacy is recalling Testosterone 100 mg pellets in Nevada 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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class I or II recalls involving significant health risks (such as lack of sterility assurance) are categorized as Severe (4) or higher, and the rule states never to go below 4 for Class I/II classifications where significant injury risk is implied by the defect type.

Plain-English summary

Partell Specialty Pharmacy is recalling Testosterone 100 mg pellets packaged in amber vials. The recall is limited to products distributed in Nevada. The firm is conducting this recall because the drug products were sterilized using a non-approved method, which raises concerns about the assurance of sterility.

The recall includes multiple lots of the product with specific expiration dates ranging from March 2018 to August 2018. The source text does not specify the total number of units recalled or report any illnesses or injuries associated with the use of these products.

Consumers who have these specific lots of Testosterone 100 mg pellets should stop using them and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Testosterone 100 mg pellet 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 — Injectable Sterile Drug
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 (20)

  • Lot#: 20171212@17
  • BUD 06/10/2018
  • 20180205@40
  • BUD 08/04/2018
  • 20180208@42
  • BUD 08/07/2018
  • 20170929@42
  • BUD 03/28/2018
  • 20171013@33
  • BUD 04/11/2018
  • 20171020@25
  • BUD 04/18/2018
  • 20171025@52
  • BUD 04/23/2018
  • 20171101@70
  • BUD 04/30/2018
  • 20171106@31
  • BUD 05/05/2018
  • 20171116@17
  • BUD: 05/15/2018

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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