PlainRecalls
FDA Drug Moderate Class II Terminated

Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 12 Capsules NDC 75834-020-12 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827 USA

Reported: June 2, 2021 Initiated: March 15, 2021 #D-0532-2021

Product Description

Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 12 Capsules NDC 75834-020-12 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827 USA

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Details

Recalling Firm
Cardinal Health Inc.
Units Affected
205 bottles
Distribution
FL, GA, SC
Location
Dublin, OH

Frequently Asked Questions

What product was recalled?
Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 12 Capsules NDC 75834-020-12 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827 USA. Recalled by Cardinal Health Inc.. Units affected: 205 bottles.
Why was this product recalled?
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 2, 2021. Severity: Moderate. Recall number: D-0532-2021.