May 8, 2019DrugsFDA
Advantice Health recalls Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%; full case of 12-2 oz. cans only;
Hazard: Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
May 8, 2019DrugsFDA
Advantice Health recalls Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%, Net WT 2.75 oz (78g); Distributed
Hazard: Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
May 8, 2019DrugsFDA
American Health Packaging recalls GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and Distributed by: American Health
Hazard: Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.
May 8, 2019DrugsFDA
US Worldmeds LLC recalls Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malignant hyperthermia, For Intravenous Use Only
Hazard: Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
May 8, 2019DrugsFDA
Pacifico National, Inc. dba AmEx Pharmacy recalls BEVACIZUMAB 1.25 mg/0.05 mL 31G MJ syringe Intravitreal Injection. This biologic product was repackaged by AmEx Pharmac
Hazard: Defective Delivery System: difficult to express
May 8, 2019DrugsFDA
RemedyRepack Inc. recalls Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
May 8, 2019DrugsFDA
Torrent Pharma Inc. recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC: 13668-118-30) b) 90-count (NDC: 1
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
May 8, 2019DrugsFDA
Torrent Pharma Inc. recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) 90-count (NDC: 13668-117-90), b) 1000-count (N
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
May 8, 2019DrugsFDA
Torrent Pharma Inc. recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC:
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
May 8, 2019DrugsFDA
Torrent Pharma Inc. recalls Losartan Potassium Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1000-count (NDC: 13668-115-10) per bottle, R
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
May 8, 2019DrugsFDA
Torrent Pharma Inc. recalls Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)1000-count (NDC: 13668-409-10) per bottle, Rx
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
May 8, 2019DrugsFDA
Torrent Pharma Inc. recalls Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)1000-count (NDC: 13668-113-10) per bottle, Rx
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
May 8, 2019DrugsFDA
Legacy Pharmaceutical Packaging LLC recalls Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH 45202
Hazard: CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)
May 8, 2019DrugsFDA
Customceutical Compounding recalls TriMix MEDIUM (Papaverine HCL 21 mg/mL Phentolamine Mesylate 0.7 mg/mL Alprostadil 7 mcg/mL), 2 mL multidose MDV Inj. Co
Hazard: Lack of assurance of sterility for injectables and solutions intended to be sterile.
May 8, 2019DrugsFDA
Customceutical Compounding recalls Trimix HIGH (Papaverine HCl 30 mg/mL Phentolamine Mesylate 2 mg/mL Alprostadil 20 mcg/mL), 2 mL multidose vial MDV Inj.
Hazard: Lack of assurance of sterility for injectables and solutions intended to be sterile.
May 8, 2019DrugsFDA
Customceutical Compounding recalls Test PROCYP (TESTOSTERONE CYPIONATE 200MG/ML TESTOSTERONE PROPIONATE 20MG/ML), 5 ML MULTIDOSE VIAL INJ COMPOUNDED. Custo
Hazard: Lack of assurance of sterility for injectables and solutions intended to be sterile.
May 8, 2019DrugsFDA
Customceutical Compounding recalls Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOSE VIAL COMPOUNDED. Customceutical Compound
Hazard: Lack of assurance of sterility for injectables and solutions intended to be sterile.
May 8, 2019DrugsFDA
Customceutical Compounding recalls Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOSE VIAL COMPOUNDED. Customceutical Compound
Hazard: Lack of assurance of sterility for injectables and solutions intended to be sterile.
May 8, 2019DrugsFDA
Customceutical Compounding recalls Lipoplex (METHIONINE 25 MG/ML INOSITOL 50 MG/ML CHOLINE CHLORIDE 50 MG/ML HYDROXOCOBALAMIN 500 MC/ML DEXPANTHENOL 50 MG/
Hazard: Lack of assurance of sterility for injectables and solutions intended to be sterile.
May 8, 2019DrugsFDA
Customceutical Compounding recalls HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL) inj 5 mL multidose vial compounded. Customceutical Compounding 461
Hazard: Lack of assurance of sterility for injectables and solutions intended to be sterile.
May 8, 2019DrugsFDA
Customceutical Compounding recalls Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE VIAL MDV Compounded. Customceutical Compounding 4611 E. Shea B
Hazard: Lack of assurance of sterility for injectables and solutions intended to be sterile.
May 8, 2019DrugsFDA
Customceutical Compounding recalls BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML), 10 ML MULTIDOSE VIAL MDV INJ CO
Hazard: Lack of assurance of sterility for injectables and solutions intended to be sterile.
May 8, 2019DrugsFDA
Customceutical Compounding recalls BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML), 10 ML MULTIDOSE VIAL MDV INJ CO
Hazard: Lack of assurance of sterility for injectables and solutions intended to be sterile.
May 8, 2019DrugsFDA
Advanced Pharma Inc. recalls HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% Sodium Chloride 100 mL, Sterile single use
Hazard: Sub-potency
May 8, 2019DrugsFDA
AVKARE Inc. recalls Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc.
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
May 8, 2019DrugsFDA
AVKARE Inc. recalls Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc.
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
May 1, 2019DrugsFDA
LUPIN SOMERSET recalls Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufactured by: Novel Laboratories, Inc. Somerset
Hazard: Failed Impurities/Degradation Specifications
May 1, 2019DrugsFDA
LUPIN SOMERSET recalls Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc.
Hazard: Failed Impurities/Degradation Specifications
May 1, 2019DrugsFDA
LUPIN SOMERSET recalls Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc.
Hazard: Failed Impurities/Degradation Specifications
May 1, 2019DrugsFDA
LUPIN SOMERSET recalls Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured by: Novel Laboratories, Inc.
Hazard: Failed Impurities/Degradation Specifications