HCG 1000 Units/mL SUB-Q Injection recalled over sterility concerns

Recall date

September 3, 2015

Source

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

Official notice title

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma recalls HCG 1000 Units/mL SUB-Q Injection, packaged in a)1.5 mL, b) 2 mL, c) 2.4 mL, d) 4 mL, e) 6 mL, f) 7.5 mL, g) 8 mL, and…

Recall number

D-306-2016

FDA classification

Class II

Brand / firm

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HCG 1000 Units/mL SUB-Q Injection, packaged in a)1.5 mL, b) 2 mL, c) 2.4 mL, d) 4 mL, e) 6 mL, f) 7.5 mL, g) 8 mL, and h) 9 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.