Kalman Health & Wellness, Inc. dba Essential Wellness Pharma recalls LIPO B Injection, packaged in a) 2 mL, b) 12 mL, c) 15 mL, or d) 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625
Recalled November 25, 2015 · FDA recall D-312-2016 · 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
76 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
LIPO B Injection, packaged in a) 2 mL, b) 12 mL, c) 15 mL, or d) 30 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 →