Recalls / Class II

Class IID-0989-2023

Product

potassium phosphate 15 mmole added to 0.9% sodium Chloride 250 mL, IV Bag, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6060-1

Affected lot / code info

Lot: 36-239332, Exp. 7/11/2023; 36-241113, Exp. 7/18/2023; 36-242467, 7/25/2023; 36-243530, 36-243659, Exp. 7/30/2023; 36-244888, 8/1/2023, 36-245657, 36-245658, Exp. 8/2/2023; 36-246835, Exp. 8/7/2023; 36-247595, Exp. 8/9/2023; 36-248736, Exp. 8/15/2023; 36-248984, 36-248985, Exp. 8/16/2023; 36-250054, 36-250055, 36-250056, 36-250057, 36-250058, Exp. 8/22/2023; 36-251046, 36-251047, 36-251048, 36-251049, Exp. 8/24/2023; 36-251975, Exp. 8/30/2023; 36-255877, 36-255878, 36-255879, Exp. 9/10/2023.

Why it was recalled

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

Recalling firm

Firm

Central Admixture Pharmacy Services, Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

2200 S 43rd Ave, N/A, Phoenix, Arizona 85043-3909

Distribution

Quantity

7469 bags

Distribution pattern

Nationwide in the USA

Timeline

Recall initiated

2023-07-14

FDA classified

2023-08-01

Posted by FDA

2023-08-09

Terminated

2025-03-28

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0989-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.