HCG 5 recalled over sterility concerns

Recall date

January 12, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

The Compounding Pharmacy of America recalls HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Compounded by The Compo…

Recall number

D-0600-2018

FDA classification

Class I

Brand / firm

The Compounding Pharmacy of America

Sold / distributed

TN, SC

Why it was recalled

Non-Sterility

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Compounded by The Compounding Pharmacy of America, 6216 Highland Place Way, Ste. 101A Knoxville, TN 37919 Ph (855) 277-2488 Fax (888) 689-9892