potassium phosphate, 30 mmole added to 0.9% sodium Chloride 500mL, IV Bag, RX Only, Central Admix...

FDA Recall #D-0990-2023 — Class II — July 14, 2023

Recall #D-0990-2023 Date: July 14, 2023 Classification: Class II Status: Terminated

Product Description

potassium phosphate, 30 mmole added to 0.9% sodium Chloride 500mL, IV Bag, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7016-1

Reason for Recall

Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

Recalling Firm

Central Admixture Pharmacy Services, Inc. — Phoenix, AZ

Classification

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

Product Type

Drugs

Product Quantity

234 bags

Distribution

Nationwide in the USA

Code Information

Lot: 36-256240, Exp.9/12/2023.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated