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 h
Recalled November 25, 2015 · FDA recall D-306-2016 · Kalman Health & Wellness, Inc.
Hazard
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. · FDA Class II
Units
49 vials
Sold at
Nationwide
Description
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.
Product
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.
Manufacturer(s)
Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →