FoodSep 1, 2021
RMH Foods Gordon Choice Deli Style Tuna Salad, Refrigerated, 4 Lb recall — FDA F-0878-2021
Undeclared wheat and tuna
Class IIFDA: TerminatedRMH Foods
September 2021 recalls — page 13
These records include useful source details for the selected month.
DrugSep 1, 2021
RemedyRepack Carvedilol 25 mg, 180-count bottle recall — FDA D-0754-2021
A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.
Class IIFDA: TerminatedRemedyRepack Inc.
DrugSep 1, 2021
ANHUI WELCOME FOREIGN TRADE CO Pi yen chin Ophthalmic Redness Reliever Drops Made in China recall — FDA D-0755-2021
Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, they are manufactured as nasal drops and sterility cannot be assured.
Class IIFDA: TerminatedANHUI WELCOME FOREIGN TRADE CO., LTD.
DrugSep 1, 2021
XELLIA PHARMACEUTICALS USA Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile recall — FDA D-0756-2021
Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of…
Class IIFDA: TerminatedXELLIA PHARMACEUTICALS USA, LLC
DrugSep 1, 2021
XELLIA PHARMACEUTICALS USA Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile recall — FDA D-0757-2021
Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of…
Class IIFDA: TerminatedXELLIA PHARMACEUTICALS USA, LLC
DrugSep 1, 2021
Bleomycin for Injection, USP recall — FDA D-0771-2021
Labeling: Not elsewhere classified: Mislabeling
Class IIIFDA: TerminatedHikma Pharmaceuticals USA Inc.
DrugSep 1, 2021
Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box recall — FDA D-0773-2021
Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.
Class IIFDA: TerminatedEli Lilly & Company
DrugSep 1, 2021
Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle recall — FDA D-0772-2021
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Class IFDA: TerminatedKVK-Tech, Inc.
DrugSep 1, 2021
Professional Disposables International PDI Duo-Swab Povidone-Iodine Cleansing Scrub recall — FDA D-0764-2021
SubPotent: Out of Specification
Class IIFDA: TerminatedProfessional Disposables International, Inc.
DrugSep 1, 2021
SterRx Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL) recall — FDA D-0767-2021
Non-Sterility: firm's third party lab confirmed microbial contamination.
Class IFDA: TerminatedSterRx, LLC
DrugSep 1, 2021
Custopharm FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial recall — FDA D-0765-2021
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
Class IIFDA: TerminatedCustopharm, Inc.
VehicleSep 1, 2021
Volvo Car USA retractor recall — NHTSA campaign 21V682000
Volvo Car USA, LLC (Volvo Car) is recalling certain 2021 XC40, XC 40 Recharge, V60CC, V90, V90CC, XC90, and 2021-2022 V60, XC60, S60 vehicles. The seat belt automatic locking retractors may…
retractorVolvo Car USA, LLC
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.