PlainRecalls
FDA Drug Moderate Class II Terminated

Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

Reported: February 20, 2019 Initiated: December 17, 2018 #D-0443-2019

Product Description

Methylcobalamin lyophilized, 10,000 mcg Injection, 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
704 vials
Distribution
Nationwide in the USA.
Location
Palm Harbor, FL

Frequently Asked Questions

What product was recalled?
Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684. Recalled by Promise Pharmacy, LLC. Units affected: 704 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-0443-2019.