DrugNov 25, 2015
Downing Labs Riboflavin-5-Phosphate Injectable,10mg/mL, 10mL vial recall — FDA D-0344-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
November 2015 recalls — page 8
These records include useful source details for the selected month.
DrugNov 25, 2015
Downing Labs MIC w/Methyl B-12 Preserved Injection, 25/50/50/1mg/mL, 50mL vial recall — FDA D-0383-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
Kalman Health & Wellness, Inc. dba Essential Dexamethasone 0.4% Opth Ointment, 3.5 g recall — FDA D-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…
Class IIFDA: TerminatedKalman Health & Wellness, Inc. dba Essential Wellness…
DrugNov 25, 2015
Kalman Health & Wellness, Inc. dba Essential QUAD MIX recall — FDA D-323-2016
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…
Class IIFDA: TerminatedKalman Health & Wellness, Inc. dba Essential Wellness…
DrugNov 25, 2015
Kalman Health & Wellness, Inc. dba Essential LIPO B Injection recall — FDA D-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…
Class IIFDA: TerminatedKalman Health & Wellness, Inc. dba Essential Wellness…
DrugNov 25, 2015
US Compounding Voriconazole Solution (1% recall — FDA D-0293-2016
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class IIFDA: TerminatedUS Compounding Inc.
DrugNov 25, 2015
US Compounding Betamethasone SP, 2 mL (6 mg/mL),10 mL Multi-Dose Vial, For IM & Regional recall — FDA D-0240-2016
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class IIFDA: TerminatedUS Compounding Inc.
DrugNov 25, 2015
US Compounding Glycopyrrolate USP ( 1 mg/5 mL), 5 mL Single Use syringe, For IM or IV recall — FDA D-0253-2016
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class IIFDA: TerminatedUS Compounding Inc.
DrugNov 25, 2015
US Compounding Triamcinolone/Lidocaine (40 mg/1%/mL), 10 mL Multidose Vial, For IM & recall — FDA D-0285-2016
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class IIFDA: TerminatedUS Compounding Inc.
DrugNov 25, 2015
Kalman Health & Wellness, Inc. dba Essential TRIMIX #3 (24 mg-1 mg-20 mcg/mL) Injection, 5 recall — FDA D-334-2016
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…
Class IIFDA: TerminatedKalman Health & Wellness, Inc. dba Essential Wellness…
DrugNov 25, 2015
Downing Labs Folic Acid Injection, 10mg/mL, 30mL vial recall — FDA D-0371-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
Kalman Health & Wellness, Inc. dba Essential sermorelin 1000 mcg/mL / LIDO 0.2% Injection, 6 recall — FDA D-326-2016
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…
Class IIFDA: TerminatedKalman Health & Wellness, Inc. dba Essential Wellness…
DrugNov 25, 2015
US Compounding Cyclo/PE/Trop PF (1%/2.5%/1%), 3 mL dropper bottle, For topical ophthalmic recall — FDA D-0244-2016
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class IIFDA: TerminatedUS Compounding Inc.
DrugNov 25, 2015
Kalman Health & Wellness, Inc. dba Essential HCG 5000 Units/mL Injection, 0.4 mL vials recall — FDA D-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…
Class IIFDA: TerminatedKalman Health & Wellness, Inc. dba Essential Wellness…
DrugNov 25, 2015
Downing Labs Testosterone Cypionate Injection (Sesame Oil), 200mg/mL, 10mL vial recall — FDA D-0379-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
Kalman Health & Wellness, Inc. dba Essential HCG 2000 Units/mL Injection recall — FDA D-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…
Class IIFDA: TerminatedKalman Health & Wellness, Inc. dba Essential Wellness…
DrugNov 25, 2015
Kalman Health & Wellness, Inc. dba Essential Testosterone CYP/ENAN/PROP Injection in recall — FDA D-331-2016
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…
Class IIFDA: TerminatedKalman Health & Wellness, Inc. dba Essential Wellness…
DrugNov 25, 2015
US Compounding Triamcinolone diacetate USP (40 mg/mL), 30 mL Multi-Dose Vial, For IM & recall — FDA D-0286-2016
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class IIFDA: TerminatedUS Compounding Inc.
DrugNov 25, 2015
Par Pharmaceutical Meclizine Hydrochloride Tablets USP, 25 mg Tablets recall — FDA D-0234-2016
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Class IIIFDA: TerminatedPar Pharmaceutical Inc.
DrugNov 25, 2015
US Compounding Alprostadil (PGE-1), 5 mL (40 mcg/mL) in 10 mL Multi-Dose Vial recall — FDA D-0237-2016
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class IIFDA: TerminatedUS Compounding Inc.
DrugNov 25, 2015
Downing Labs B12 Injection 12.5/12.5MG, 3mL recall — FDA D-0366-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
Kalman Health & Wellness, Inc. dba Essential MIC Injection, 30 mL vials recall — FDA D-319-2016
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…
Class IIFDA: TerminatedKalman Health & Wellness, Inc. dba Essential Wellness…
DrugNov 25, 2015
Downing Labs Procaine Injectables 20mg/mL and 2%, 50mL vial recall — FDA D-0345-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
US Compounding Dex Combo recall — FDA D-0249-2016
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class IIFDA: TerminatedUS Compounding Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.