Kalman Health & Wellness, Inc. dba Essential Wellness Pharma recalls Acetylcysteine 10% Oph Solution, packaged in a) 6 mL and b) 12 mL dropper bottles, Rx only, Essential Wellness PHARMACY,
Recalled November 25, 2015 · FDA recall D-298-2016 · 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
2 dropper bottles
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
Acetylcysteine 10% Oph Solution, packaged in a) 6 mL and b) 12 mL dropper bottles, 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 →