FDAClass IIApril 25, 2018

Pregnenolone 100 mg recall: Sterility Concern

Pregnenolone 100 mg (SD) pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800

Why was Pregnenolone 100 mg recalled?

Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot#: 20171017@85, BUD: 04/15/2018

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
Recalling firm
Partell Specialty Pharmacy
Quantity
one vial
Distribution
NV only
Recall date
April 25, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls