DrugNov 20, 2019
Isotretinoin Capsules, USP 10 mg recall — FDA D-0321-2020
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Class IIIFDA: TerminatedAmneal Pharmaceuticals, Inc.
Monthly breakdown
2019 recalls by month
Select a month to review the recall records reported during that period.
December 2019321 records · 4 categoriesNovember 2019597 records · 4 categoriesOctober 2019525 records · 4 categoriesSeptember 2019268 records · 4 categoriesAugust 2019505 records · 4 categoriesJuly 2019680 records · 4 categoriesJune 2019445 records · 4 categoriesMay 2019396 records · 4 categoriesApril 2019242 records · 4 categoriesMarch 2019250 records · 4 categoriesFebruary 2019381 records · 4 categoriesJanuary 2019142 records · 4 categories
2019 recalls — page 30
Records are ordered by the best available source date.
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-Neuro, 10 mL Sterile multi-dose vial recall — FDA D-0346-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-Systemic Detox, 10 mL Sterile multi-dose vial recall — FDA D-0331-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 recall — FDA D-0532-2020
Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Class IIFDA: TerminatedKVK-Tech, Inc.
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-Relief +, 10 mL Sterile multi-dose vial recall — FDA D-0342-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-MuSkel-Neural, 10 mL Sterile multi-dose vial recall — FDA D-0327-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-Facial, 10 mL Sterile multi-dose vial recall — FDA D-0344-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-Ithurts, 10 mL Sterile multi-dose vial recall — FDA D-0329-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
Apotex Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer recall — FDA D-0319-2020
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class IIFDA: CompletedApotex Inc.
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-Immunexx, 10 mL Sterile multi-dose vial recall — FDA D-0341-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-Arthros, 10 mL Sterile multi-dose vial recall — FDA D-0340-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
Golden State Medical Supply GSMS: Ranitidine Capsules 150 mg recall — FDA D-0307-2020
CGMP Deviations: Presence of NDMA impurity detected in product.
Class IIFDA: TerminatedGolden State Medical Supply Inc.
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-Mesenchyme, 10 mL Sterile multi-dose vial recall — FDA D-0338-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
WAL-DRAM 2 (meclizine Hydrochloride) 25 mg tablets recall — FDA D-0324-2020
Subpotent Drug
Class IIIFDA: TerminatedSato Pharmaceutical Inc.
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-Infla, 10 mL Sterile multi-dose vial recall — FDA D-0334-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-GI, 10 mL Sterile multi-dose vial recall — FDA D-0339-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-Prolo, 10 mL Sterile multi-dose vial recall — FDA D-0336-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-Neuro 3, 10 mL Sterile multi-dose vial recall — FDA D-0333-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-ANS/CNS, 10 mL Sterile multi-dose vial recall — FDA D-0348-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-Lymph 1, 10 mL Sterile multi-dose vial recall — FDA D-0337-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-Collagen, 10 mL Sterile multi-dose vial recall — FDA D-0335-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-Connectissue, 10 mL Sterile multi-dose vial recall — FDA D-0326-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-Ouch, 10 mL Sterile multi-dose vial recall — FDA D-0328-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-Articula, 10 mL Sterile multi-dose vial recall — FDA D-0332-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
About the 2019 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.