MIC B12+L-Carnitine+Chromium injection, Methionine Inositol Choline Methylcobalamin+L-Carnitine+C...

FDA Recall #D-0467-2019 — Class II — December 17, 2018

Recall #D-0467-2019 Date: December 17, 2018 Classification: Class II Status: Terminated

Product Description

MIC B12+L-Carnitine+Chromium injection, Methionine Inositol Choline Methylcobalamin+L-Carnitine+Chromium, 25mg/50mg/50mg/1mg/100mg/0.4mcg/ml, 10mL, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684

Reason for Recall

Lack of sterility assurance.

Recalling Firm

Promise Pharmacy, LLC — Palm Harbor, FL

Classification

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

Product Type

Drugs

Product Quantity

64 vials

Distribution

Nationwide in the USA.

Code Information

Lot: 10102018@1 BUD: 1/8/2019

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated