DrugMay 8, 2019
US Worldmeds Revonto recall — FDA D-1275-2019
Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
Class IIFDA: TerminatedUS Worldmeds LLC
May 2019 recalls — page 15
These records include useful source details for the selected month.
DrugMay 8, 2019
RemedyRepack Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle recall — FDA D-1270-2019
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…
Class IIFDA: TerminatedRemedyRepack Inc.
DrugMay 8, 2019
Torrent Pharma Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/12.5mg, a) recall — FDA D-1268-2019
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class IIFDA: OngoingTorrent Pharma Inc.
DrugMay 8, 2019
Advantice Health Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters recall — FDA D-1280-2019
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.
Class IIIFDA: TerminatedAdvantice Health
DrugMay 8, 2019
Advanced Pharma HYDROmorphone 20 mg/100 mL Injectable Solution, Hydromorphone HCl 20 mg 0.9% recall — FDA D-1251-2019
Sub-potency
Class IIFDA: TerminatedAdvanced Pharma Inc.
DrugMay 8, 2019
Advantice Health Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters recall — FDA D-1279-2019
Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
Class IIIFDA: TerminatedAdvantice Health
DrugMay 8, 2019
Legacy Pharmaceutical Packaging Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles recall — FDA D-1263-2019
CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)
Class IIFDA: OngoingLegacy Pharmaceutical Packaging LLC
DrugMay 8, 2019
Customceutical Compounding TriMix MEDIUM recall — FDA D-1262-2019
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class IIFDA: TerminatedCustomceutical Compounding
DrugMay 8, 2019
Customceutical Compounding Test D recall — FDA D-1259-2019
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class IIFDA: TerminatedCustomceutical Compounding
DrugMay 8, 2019
Customceutical Compounding Test PROCYP recall — FDA D-1260-2019
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class IIFDA: TerminatedCustomceutical Compounding
DrugMay 8, 2019
Torrent Pharma Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90) recall — FDA D-1265-2019
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class IIFDA: OngoingTorrent Pharma Inc.
DrugMay 8, 2019
Customceutical Compounding Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE VIAL recall — FDA D-1255-2019
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class IIFDA: TerminatedCustomceutical Compounding
DrugMay 8, 2019
Torrent Pharma Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) recall — FDA D-1269-2019
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class IIFDA: OngoingTorrent Pharma Inc.
DrugMay 8, 2019
AVKARE Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose recall — FDA D-1250-2019
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…
Class IIFDA: OngoingAVKARE Inc.
DrugMay 8, 2019
Customceutical Compounding Lipoplex recall — FDA D-1257-2019
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class IIFDA: TerminatedCustomceutical Compounding
DrugMay 8, 2019
Customceutical Compounding Test D recall — FDA D-1258-2019
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class IIFDA: TerminatedCustomceutical Compounding
DrugMay 8, 2019
Customceutical Compounding BPlex recall — FDA D-1253-2019
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class IIFDA: TerminatedCustomceutical Compounding
DrugMay 8, 2019
AVKARE Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose recall — FDA D-1249-2019
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…
Class IIFDA: OngoingAVKARE Inc.
DrugMay 8, 2019
Customceutical Compounding Trimix HIGH recall — FDA D-1261-2019
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class IIFDA: TerminatedCustomceutical Compounding
DrugMay 8, 2019
Customceutical Compounding HCG recall — FDA D-1256-2019
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class IIFDA: TerminatedCustomceutical Compounding
DrugMay 8, 2019
Torrent Pharma Losartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) recall — FDA D-1267-2019
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class IIFDA: OngoingTorrent Pharma Inc.
DrugMay 8, 2019
Torrent Pharma Losartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90) recall — FDA D-1264-2019
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class IIFDA: OngoingTorrent Pharma Inc.
DrugMay 8, 2019
American Health Packaging GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10) recall — FDA D-1276-2019
Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.
Class IIFDA: TerminatedAmerican Health Packaging
DrugMay 8, 2019
Customceutical Compounding BPlex recall — FDA D-1254-2019
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class IIFDA: TerminatedCustomceutical Compounding
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.