U.S. Recalls in July 2016

July 2016 recalls — page 10

These records include useful source details for the selected month.

2016 archive →

DrugJul 20, 2016

Golden State Medical Supply DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count recall — FDA D-1255-2016

Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label is 02/2019, correct expiration date should be 02/2018

Class IIIFDA: TerminatedGolden State Medical Supply Inc.

DrugJul 20, 2016

Medaus LIPO W/LIDOCAINE #3 W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID 50MG recall — FDA D-1201-2016

Lack of Assurance of Sterility

Class IIFDA: TerminatedMedaus, Inc.

DrugJul 20, 2016

Pharmakon Pharmaceuticals Morphine Sulfate (Preserved) 2mg/mL in 0.9% Sodium Chloride 50 mL recall — FDA D-1307-2016

Lack of Assurance of Sterility

Class IIFDA: TerminatedPharmakon Pharmaceuticals, Inc.

DrugJul 20, 2016

Pharmakon Pharmaceuticals Ketamine 2 mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL recall — FDA D-1329-2016

Lack of Assurance of Sterility

Class IIFDA: TerminatedPharmakon Pharmaceuticals, Inc.

DrugJul 20, 2016

Medaus LIPO-BOOST W/PRES. (BENZYL ETOH 2%) B1-50MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-52MG recall — FDA D-1205-2016

Lack of Assurance of Sterility

Class IIFDA: TerminatedMedaus, Inc.

DrugJul 20, 2016

Pharmakon Pharmaceuticals Fentanyl Citrate 2.5 mcg/mL & Bupivacaine 0.075% in 0.9% Sodium recall — FDA D-1308-2016

Lack of Assurance of Sterility

Class IIFDA: TerminatedPharmakon Pharmaceuticals, Inc.

DrugJul 20, 2016

Pharmakon Pharmaceuticals Morphine Sulfate 1mg/mL in 0.9% Sodium Chloride 50 mL fill in a 50 recall — FDA D-1283-2016

Lack of Assurance of Sterility

Class IIFDA: TerminatedPharmakon Pharmaceuticals, Inc.

DrugJul 20, 2016

Pharmakon Pharmaceuticals Hydromorphone HCI 1 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia recall — FDA D-1312-2016

Lack of Assurance of Sterility

Class IIFDA: TerminatedPharmakon Pharmaceuticals, Inc.

DrugJul 20, 2016

Pharmakon Pharmaceuticals HYDROmorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 25 mL fill in a recall — FDA D-1305-2016

Lack of Assurance of Sterility

Class IIFDA: TerminatedPharmakon Pharmaceuticals, Inc.

DrugJul 20, 2016

Murray International Trading Co FARSER KAI YEUNG PILL recall — FDA D-1355-2016

Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.

Class IIFDA: TerminatedMurray International Trading Co., Inc.

DrugJul 20, 2016

Apotex Scientific Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles recall — FDA D-1436-2016

Failed Dissolution Specification: Out of specification dissolution results when testing product stability.

Class IIIFDA: TerminatedApotex Scientific, Inc.

DrugJul 20, 2016

Daytrana recall — FDA D-1438-2016

Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the…

Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.

DrugJul 20, 2016

Pharmakon Pharmaceuticals Promethazine 6.25 mg added to 0.9% Sodium Chloride 50 mL in 100 mL recall — FDA D-1273-2016

Lack of Assurance of Sterility

Class IIFDA: TerminatedPharmakon Pharmaceuticals, Inc.

DrugJul 20, 2016

Medaus LIPO-INJECTION W/LIDOCAINE W/PRES. (BENZYL ETOH 2%) ASCORBIC ACID-50MG, B1-50MG, B2-5 recall — FDA D-1210-2016

Lack of Assurance of Sterility

Class IIFDA: TerminatedMedaus, Inc.

DrugJul 20, 2016

Pharmakon Pharmaceuticals HYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride 30 mL fill in a recall — FDA D-1325-2016

Lack of Assurance of Sterility

Class IIFDA: TerminatedPharmakon Pharmaceuticals, Inc.

DrugJul 20, 2016

Daytrana recall — FDA D-1439-2016

Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the…

Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.

DrugJul 20, 2016

Medaus M.I.C B-COMPLEX PREMIX W/HYDROXY B12 W/PRES. (BENZALKONIUM 0.01%) HYDROXY B12 1MG recall — FDA D-1222-2016

Lack of Assurance of Sterility

Class IIFDA: TerminatedMedaus, Inc.

FoodJul 13, 2016

Norpac Foods Natural Directions Organic Green Peas, frozen, net wt recall — FDA F-1616-2016

Natural Directions Organic Green Peas are recalled because they have the potential to be contaminated with Listeria monocytogenes.

Class IFDA: TerminatedNorpac Foods, Inc. (Plant #8)

FoodJul 13, 2016

The Pictsweet Company Frozen three pepper and onion blends labeled as: a) Harris recall — FDA F-1653-2016

Products contain onions which were recalled for the possibility of Listeria monocytogenes contamination.

Class IFDA: TerminatedThe Pictsweet Company

FoodJul 13, 2016

The Pictsweet Company Harris Teeter recall — FDA F-1654-2016

Products contain onions which were recalled for the possibility of Listeria monocytogenes contamination.

Class IFDA: TerminatedThe Pictsweet Company

FoodJul 13, 2016

The Pictsweet Company Frozen seasoning blend labeled as: a) PICTSWEET recall — FDA F-1660-2016

Products contain onions which were recalled for the possibility of Listeria monocytogenes contamination.

Class IFDA: TerminatedThe Pictsweet Company

FoodJul 13, 2016

Norpac Foods Natural Directions Organic Mixed Vegetables, frozen, net wt recall — FDA F-1615-2016

Organic Mixed Vegetables are recalled because they have the potential to be contaminated with Listeria monocytogenes.

Class IFDA: TerminatedNorpac Foods, Inc. (Plant #8)

FoodJul 13, 2016

Grain Craft Kraft Cake Flour recall — FDA F-1599-2016

Possible Peanut Protein contamination.

Class IIFDA: TerminatedGrain Craft, Inc.

FoodJul 13, 2016

The Pictsweet Company PICTSWEET recall — FDA F-1664-2016

Products contain onions which were recalled for the possibility of Listeria monocytogenes contamination.

Class IFDA: TerminatedThe Pictsweet Company

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.

U.S. Recalls — July 2016

July 2016 recalls — page 10

How to use this monthly recall archive