DrugNov 25, 2015
Downing Labs Calcium Gluconate (680mOsm/L) Injection 10%, 50mL vial recall — FDA D-0363-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
November 2015 recalls — page 4
These records include useful source details for the selected month.
DrugNov 25, 2015
US Compounding Betamethasone SP PF (12 mg/mL), 2 mL Single Dose Vial, For IM & Regional recall — FDA D-0241-2016
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 Ascorbic Acid Injectable 500mg/mL recall — FDA D-0342-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
US Compounding Tropicamide 1%/Phenylephrine 2.5% recall — FDA D-0290-2016
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 Methylcobalamin 1 mg/mL (Pres Free) Injection recall — FDA D-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…
Class IIFDA: TerminatedKalman Health & Wellness, Inc. dba Essential Wellness…
DrugNov 25, 2015
US Compounding Cyclopent/PE/Tropic 2mL (1%/2.5%/0.25%), 2 mL dropper bottles recall — FDA D-0246-2016
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 Vitamin D3 Injectable, 10,000 U/mL, 10mL vial recall — FDA D-0347-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
US Compounding Hyaluronic Acid/Lidocaine PF (60 mg/2%), 3 mL Single Use Syringe, For recall — FDA D-0256-2016
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 Hydroxocobalamin Injection (Buffered) 1mg/mL, 30mL vial recall — FDA D-0365-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
Downing Labs L-Tyrosine Injectable, 25mg/mL, 30mL vial recall — FDA D-0338-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
Downing Labs Magnesium Chloride Hexahydrate Injection 200mg/mL, 50mL vial recall — FDA D-0367-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
Downing Labs Methylcobalamin Buffered Injectable, 1mg/mL recall — FDA D-0348-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
US Compounding Lidocaine 1% PF(100 mg/10 mL),10 mL Single Use Syringe, For IV Injection recall — FDA D-0261-2016
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 Methylcobalamin (12.5 mg/mL), 2.5 mL Multi-Dose Vial, For IM or SC Injection recall — FDA D-0264-2016
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 L-Glutamine Injectable, 30mg/mL, 30mL vial recall — FDA D-0337-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
US Compounding Betamethasone Combo PF 2 mL (6 mg/mL) 10 mL Multi-Dose Vial, For IM & recall — FDA D-0239-2016
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 Acetylcysteine 10% Oph Solution recall — FDA D-298-2016
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 Special Injection,12 mL vials recall — FDA D-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…
Class IIFDA: TerminatedKalman Health & Wellness, Inc. dba Essential Wellness…
DrugNov 25, 2015
US Compounding Dexamethasone Sodium Phosphate PF (10 mg/mL), 2 mL Single Use Vial, For IV or recall — FDA D-0250-2016
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 Piracetam Injection, 200mg/mL,10mL vial recall — FDA D-0372-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
Downing Labs EDTA Calcium Disodium Injectable, 300mg/mL, 50mL vial recall — FDA D-0357-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
Kalman Health & Wellness, Inc. dba Essential TRIMIX #1 Injection, 4.2 mL vials recall — FDA D-332-2016
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 Magnesium Sulfate Injection (4060mOsm/L), 50%, 50mL vial recall — FDA D-0381-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
Kalman Health & Wellness, Inc. dba Essential HCG 1000 Units/mL SUB-Q Injection recall — FDA D-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…
Class IIFDA: TerminatedKalman Health & Wellness, Inc. dba Essential Wellness…
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.