DrugNov 25, 2015
Downing Labs Sermorelin/GHRP-6/GHRP-2 Injection 3MG/3MG/3MG, 5mL vial recall — FDA D-0364-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
November 2015 recalls — page 9
These records include useful source details for the selected month.
DrugNov 25, 2015
Downing Labs Glucosamine HCL Injectable, 200mg/mL, 30mL vial recall — FDA D-0352-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
Downing Labs Magnesium Sulfate 50% Injectable, 50mL vial recall — FDA D-0350-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
Kalman Health & Wellness, Inc. dba Essential Testosterone Cypionate 200 mcg/mL in Corn Oil recall — FDA D-329-2016
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 Acetyl-L-Carnitine Injectable, 100mg/mL, 30mL vial, L-Carnitine Injection recall — FDA D-0341-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
US Compounding Phenylephrine 1.5%/ Lidocaine 1%, 1 mL Single Use Vial, For Intracameral recall — FDA D-0273-2016
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 Testosterone CYP/ENAN/PROP Injection, 66.6 recall — FDA D-330-2016
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 Progesterone 100 mg/mL IM* Injection in Sesame recall — FDA D-320-2016
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 DUAL TEST CYP/ENA 1:1 200 mg/mL Injection recall — FDA D-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…
Class IIFDA: TerminatedKalman Health & Wellness, Inc. dba Essential Wellness…
DrugNov 25, 2015
US Compounding Tropicamide 0.5%/ Phenylephrine 5%, 2 mL Dropper Bottle For Topical recall — FDA D-0289-2016
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 Morphine PF (2 mg/2 mL), 2 mL Single Use Vial, For IV or IM Administration recall — FDA D-0270-2016
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-Tryptophan Injectable, 30mg/mL, 30mL vial recall — FDA D-0339-2016
Lack of Assurance of Sterility
Class IIFDA: TerminatedDowning Labs, LLC
DrugNov 25, 2015
US Compounding HCG/B12 (5,000 units, 0.6 mg) 5 mL, Multi-Dose Vial, For IM or SC Injection recall — FDA D-0254-2016
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 in Corn Oil Injection, 2 recall — FDA D-321-2016
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…
FoodNov 18, 2015
Andrew & Williamson Fresh Produce 5/4 Limited Edition Cucumber Carton, Sizes 24SP, 36/36SP recall — FDA F-0189-2016
Andrew and Williamson Fresh Produce (A&W) is recalling all cucumbers sold under the Limited Edition label because it may be contaminated with Salmonella.
Class IFDA: TerminatedAndrew & Williamson Fresh Produce
FoodNov 18, 2015
Appeeling Fruit Tart Fresh, Apple Edges, Net Wt recall — FDA F-0186-2016
Appeeling Fruit Inc. in Dauberville, Penn. is voluntarily recalling consumer packages of fresh sliced apples with Best-if-Used-by dates of 09/14/15 and 09/21/15, due to the potential to be…
Class IFDA: TerminatedAppeeling Fruit, Inc.
FoodNov 18, 2015
The Great Gourmet 32/1 oz recall — FDA F-0179-2016
The firm is missing important labeling information for three of its products (The Great Gourmet 10/3 oz. Coconut seafood crab cake, The Great Gourmet 11/3 oz. Eastern Shore crab and shrimp…
Class IIFDA: TerminatedThe Great Gourmet Inc.
FoodNov 18, 2015
Appeeling Fruit Sweet Fresh, Apple Wedges, Net Wt recall — FDA F-0181-2016
Appeeling Fruit Inc. in Dauberville, Penn. is voluntarily recalling consumer packages of fresh sliced apples with Best-if-Used-by dates of 09/14/15 and 09/21/15, due to the potential to be…
Class IFDA: TerminatedAppeeling Fruit, Inc.
FoodNov 18, 2015
Bonduelle USA Frozen Corn distributed under the following labels and sizes recall — FDA F-0180-2016
One code of Wylwood brand Frozen Whole Kernel Corn was found to be contaminated with Listeria monocytogenes based on sampling and analysis by the State of Tennessee. The firm decided to…
Class IIFDA: TerminatedBonduelle USA Inc.
FoodNov 18, 2015
Appeeling Fruit Dauberville, PA 19533 recall — FDA F-0182-2016
Appeeling Fruit Inc. in Dauberville, Penn. is voluntarily recalling consumer packages of fresh sliced apples with Best-if-Used-by dates of 09/14/15 and 09/21/15, due to the potential to be…
Class IFDA: TerminatedAppeeling Fruit, Inc.
FoodNov 18, 2015
Andrew & Williamson Fresh Produce 1 1/9 Bushel Limited Edition Cucumber Carton, Sizes recall — FDA F-0190-2016
Andrew and Williamson Fresh Produce (A&W) is recalling all cucumbers sold under the Limited Edition label because it may be contaminated with Salmonella.
Class IFDA: TerminatedAndrew & Williamson Fresh Produce
FoodNov 18, 2015
The Great Gourmet 11/3 oz recall — FDA F-0178-2016
The firm is missing important labeling information for three of its products (The Great Gourmet 10/3 oz. Coconut seafood crab cake, The Great Gourmet 11/3 oz. Eastern Shore crab and shrimp…
Class IIFDA: TerminatedThe Great Gourmet Inc.
FoodNov 18, 2015
The Great Gourmet 10/3 oz recall — FDA F-0177-2016
The firm is missing important labeling information for three of its products ( The Great Gourmet 10/3 oz. Coconut seafood crab cake, The Great Gourmet 11/3 oz. Eastern Shore crab and shrimp…
Class IIFDA: TerminatedThe Great Gourmet Inc.
FoodNov 18, 2015
Appeeling Fruit Wegman's, Organic Apple Wedges, Net Wt recall — FDA F-0185-2016
Appeeling Fruit Inc. in Dauberville, Penn. is voluntarily recalling consumer packages of fresh sliced apples with Best-if-Used-by dates of 09/14/15 and 09/21/15, due to the potential to be…
Class IFDA: TerminatedAppeeling Fruit, 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.