Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
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.
TerminatedSterility / contaminationKalman Health & Wellness, Inc. dba Essential Wellness PharmaD-316-2016
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.
TerminatedSterility / contaminationKalman Health & Wellness, Inc. dba Essential Wellness PharmaD-315-2016
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.
TerminatedSterility / contaminationKalman Health & Wellness, Inc. dba Essential Wellness PharmaD-314-2016
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.
TerminatedSterility / contaminationKalman Health & Wellness, Inc. dba Essential Wellness PharmaD-313-2016
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.
TerminatedSterility / contaminationKalman Health & Wellness, Inc. dba Essential Wellness PharmaD-312-2016
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.
TerminatedSterility / contaminationKalman Health & Wellness, Inc. dba Essential Wellness PharmaD-311-2016
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.
TerminatedSterility / contaminationKalman Health & Wellness, Inc. dba Essential Wellness PharmaD-310-2016
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.
TerminatedSterility / contaminationKalman Health & Wellness, Inc. dba Essential Wellness PharmaD-309-2016
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.
TerminatedSterility / contaminationKalman Health & Wellness, Inc. dba Essential Wellness PharmaD-308-2016
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.
TerminatedSterility / contaminationKalman Health & Wellness, Inc. dba Essential Wellness PharmaD-307-2016
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.
TerminatedSterility / contaminationKalman Health & Wellness, Inc. dba Essential Wellness PharmaD-306-2016
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.
TerminatedSterility / contaminationKalman Health & Wellness, Inc. dba Essential Wellness PharmaD-305-2016
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.
TerminatedSterility / contaminationKalman Health & Wellness, Inc. dba Essential Wellness PharmaD-304-2016
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.
TerminatedSterility / contaminationKalman Health & Wellness, Inc. dba Essential Wellness PharmaD-303-2016
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.
TerminatedSterility / contaminationKalman Health & Wellness, Inc. dba Essential Wellness PharmaD-302-2016
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.
TerminatedSterility / contaminationKalman Health & Wellness, Inc. dba Essential Wellness PharmaD-301-2016
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.
TerminatedSterility / contaminationKalman Health & Wellness, Inc. dba Essential Wellness PharmaD-300-2016
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.
TerminatedSterility / contaminationKalman Health & Wellness, Inc. dba Essential Wellness PharmaD-299-2016
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.
TerminatedSterility / contaminationKalman Health & Wellness, Inc. dba Essential Wellness PharmaD-298-2016
Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.
Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.