Pregnenolone 100 mg (SD) pellet, amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern...

FDA Recall #D-0649-2018 — Class II — March 22, 2018

Recall #D-0649-2018 Date: March 22, 2018 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

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

Recalling Firm

Partell Specialty Pharmacy — Las Vegas, NV

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

one vial

Distribution

NV only

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated