PlainRecalls
FDA Drug Moderate Class II Terminated

Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

Reported: February 20, 2019 Initiated: December 17, 2018 #D-0440-2019

Product Description

Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

Reason for Recall

Lack of sterility assurance.

Details

Recalling Firm
Promise Pharmacy, LLC
Units Affected
210 5 ml vials
Distribution
Nationwide in the USA.
Location
Palm Harbor, FL

Frequently Asked Questions

What product was recalled?
Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684. Recalled by Promise Pharmacy, LLC. Units affected: 210 5 ml vials.
Why was this product recalled?
Lack of sterility assurance.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 20, 2019. Severity: Moderate. Recall number: D-0440-2019.