DrugNov 25, 2015
Downing Labs Methylcobalamin Buffered Injectable, 5mg/mL, 30mL vial recall — FDA D-0354-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
Monthly breakdown
2015 recalls by month
Select a month to review the recall records reported during that period.
December 201593 records · 2 categoriesNovember 2015364 records · 2 categoriesOctober 2015140 records · 2 categoriesSeptember 2015269 records · 2 categoriesAugust 2015193 records · 2 categoriesJuly 2015660 records · 2 categoriesJune 2015111 records · 2 categoriesMay 2015295 records · 2 categoriesApril 2015719 records · 2 categoriesMarch 2015168 records · 2 categoriesFebruary 2015284 records · 2 categoriesJanuary 201543 records · 2 categories
2015 recalls — page 11
Records are ordered by the best available source date.
DrugNov 25, 2015
US Compounding Phenylephrine PF Sterile Solution (2.5%), 3 mL Single Use Ophthalmic Dropper recall — FDA D-0277-2016
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 DMPS Injectable, 50mg/mL, 5mL vial recall — FDA D-0359-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
Kalman Health & Wellness, Inc. dba Essential Sermorelin 1000 mcg/mL SUB-Q* Injection recall — FDA D-325-2016
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 Methylcobalamin 25 mg/mL PF Injection, 0.5 mL recall — FDA D-317-2016
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 Tri-Mix 30/1/10 recall — FDA D-0288-2016
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 #4 (27 mg-1.5 mg-50 mcg/mL) Injection, 5 recall — FDA D-335-2016
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 Betamethasone Combo 10 mL (7 mg/mL), 10 mL Multi-Dose Vial,for IM & Regional recall — FDA D-0238-2016
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 #2 (24 mg-0.8 mg-20 mcg /mL) Injection recall — FDA D-333-2016
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 Bi-Mix recall — FDA D-0242-2016
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 acetonide, USP (50 mg/mL), 10 mL Multi-Dose Vial, For IM & recall — FDA D-0284-2016
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 Vancomycin Ophthalmic PF 0.5 mL (5 mg/0.5 mL recall — FDA D-0291-2016
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 Glycerin Opth Solution, 10 mL dropper bottles recall — FDA D-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…
Class IIFDA: TerminatedKalman Health & Wellness, Inc. dba Essential Wellness…
DrugNov 25, 2015
US Compounding L-Cysteine PF (50 mg/mL), 10 mL Single Dose Vial, For IV Use After Dilution recall — FDA D-0260-2016
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 20 mg/mL PF Injection, 0.05 mL recall — FDA D-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…
Class IIFDA: TerminatedKalman Health & Wellness, Inc. dba Essential Wellness…
DrugNov 25, 2015
US Compounding Lincomycin/Lidocaine (300 mg/1%/mL), 10 mL Multi-Dose Vial, For IV Injection recall — FDA D-0262-2016
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 Phenylephrine PF (1 mg/10 mL), 10 mL Single Use Syringe, For IV Use recall — FDA D-0276-2016
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 Progesterone 100 mg/mL Ethyl Oleate Injection recall — FDA D-322-2016
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 MedroxyPROGESTERone/Lidocaine (150 mg/mL/1%) 10 mL Multi-Dose Vial, For IM recall — FDA D-0263-2016
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 Cyclo/PE/Tropic/Ketor (1%/2.5%/1%/0.5%), 10 mL Opthalmic dropper bottle, For recall — FDA D-0245-2016
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 TNPRDC Injection, 6 mL vial recall — FDA D-0358-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
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
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…
About the 2015 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.