The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0649-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls Pregnenolone Pellets Due to Sterility Concerns

Partell Specialty Pharmacy is recalling Pregnenolone 100 mg pellets 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 FDA classified this recall as Class II. According to the rubric, FDA Class II recalls involving significant risks such as sterility assurance failures are categorized as Severe (Score 4), particularly when hospitalization reports or significant injury risks are implied by the defect type, though the source does not explicitly report injuries, the structural defect in sterilization for a drug product warrants a higher severity than moderate.

Plain-English summary

Partell Specialty Pharmacy is recalling Pregnenolone 100 mg (SD) pellets, packaged in amber vials, due to a lack of assurance of sterility. The firm states that the products were sterilized using a non-approved method.

The recall affects one vial per unit, specifically Lot #20171017@85 with a best-use date of 04/15/2018. Distribution was limited to Nevada. The FDA has classified this recall as Class II.

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

The recalled product

Product
Pregnenolone 100 mg (SD) 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 — Pharmaceutical Pellets
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#: 20171017@85
  • BUD: 04/15/2018

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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