FoodAug 14, 2019
Wismettac Asian Foods Shirakiku FISH CAKE IKA MAKI SK F recall — FDA F-1977-2019
Fish Cake items contain possible contaminating undeclared egg, milk and shellfish.
Class IFDA: TerminatedWismettac Asian Foods, Inc.
August 2019 recalls — page 17
These records include useful source details for the selected month.
FoodAug 14, 2019
Wismettac Asian Foods Shirakiku FISH CAKE GOBO MAKI SK F: 20/ 150G, Net Wt recall — FDA F-1976-2019
Fish Cake items contain possible contaminating undeclared egg, milk and shellfish.
Class IFDA: TerminatedWismettac Asian Foods, Inc.
FoodAug 14, 2019
CH Guenther & Sons Winco Foods, Taco Seasoning Mild, Net Wt recall — FDA F-2087-2019
Products contains an ingredient (cumin) potentially contaminated with Salmonella.
Class IIFDA: TerminatedCH Guenther & Sons, Inc.
DrugAug 14, 2019
Herbal Doctor Remedies Pain Stopper, 500 mg Capsules, 90-count bottles recall — FDA D-1612-2019
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class IIFDA: TerminatedHerbal Doctor Remedies
DrugAug 14, 2019
Herbal Doctor Remedies Awake, 500 mg Capsules, 90-count bottles recall — FDA D-1589-2019
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class IIFDA: TerminatedHerbal Doctor Remedies
DrugAug 14, 2019
Herbal Doctor Remedies Pain Away, 500 mg Capsules, 90-count bottles recall — FDA D-1611-2019
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class IIFDA: TerminatedHerbal Doctor Remedies
DrugAug 14, 2019
Mometasone Furoate Cream USP, 0.1% recall — FDA D-1586-2019
GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty.
Class IIFDA: TerminatedGlenmark Pharmaceuticals Inc., USA
DrugAug 14, 2019
RXQ Compounding STERILE WATER FOR INJECTION USP, [10, 30, or 50 ML] per Vial, RXQ recall — FDA D-1707-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedRXQ Compounding LLC
DrugAug 14, 2019
Unipharma, LLC CVS Health Children's Nasal Saline Drops with Himalayan Salt Saline Nasal recall — FDA D-1633-2019
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class IIFDA: TerminatedUnipharma, LLC.
DrugAug 14, 2019
Herbal Doctor Remedies Cardia Forte, 500 mg Capsules, 90-count bottles, Herbal Doctor recall — FDA D-1592-2019
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class IIFDA: TerminatedHerbal Doctor Remedies
DrugAug 14, 2019
Lovastatin Tablets USP, 40 mg recall — FDA D-1584-2019
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Class IIIFDA: TerminatedAmerican Health Packaging
DrugAug 14, 2019
Herbal Doctor Remedies Hair Back, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies recall — FDA D-1599-2019
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class IIFDA: TerminatedHerbal Doctor Remedies
DrugAug 14, 2019
Unipharma, LLC CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl recall — FDA D-1631-2019
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class IIFDA: TerminatedUnipharma, LLC.
DrugAug 14, 2019
Unipharma, LLC DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL recall — FDA D-1632-2019
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Class IIFDA: TerminatedUnipharma, LLC.
DrugAug 14, 2019
AAA Pharmaceutical Smart Sense Regular Strength Aspirin Tablets, 325 mg packed in a) 100 recall — FDA D-1585-2019
Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration date of 9/2022 applied to the labeling, where the actual expiration date is 10/2021.
Class IIIFDA: TerminatedAAA Pharmaceutical, Inc.
DrugAug 14, 2019
Herbal Doctor Remedies Worm Off, 500 mg Capsules, 90-count bottles, Herbal Doctor Remedies recall — FDA D-1620-2019
CGMP Deviations: Products were manufactured outside of the controls required by current Good Manufacturing Practices.
Class IIFDA: TerminatedHerbal Doctor Remedies
VehicleAug 14, 2019
BMW tie rod recall — NHTSA campaign 19V601000
BMW of North America, LLC (BMW) is recalling certain 2018-2019 BMW X1 sDrive28i, X1 xDrive28i, 2019 X2 xDrive28i, MINI Cooper S Convertible, Countryman, and John Cooper Works Countryman…
tie rodBMW of North America, LLC
VehicleAug 13, 2019
Telluride rear/other recall — NHTSA campaign 19V594000
Kia Motors America (Kia) is recalling certain 2020 Telluride vehicles. The seat belt assemblies in the front passenger, second, and/or third row seats may not tightly secure a child…
rear/otherKia Motors America
Medical DeviceAug 7, 2019
Burlington Medical 1 pc Full Wrap Back Relief Apron, Product Number B52 Front & Back Apron recall — FDA Z-2120-2019
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
Class IIFDA: TerminatedBurlington Medical, LLC
Medical DeviceAug 7, 2019
Burlington Medical Frontal Stretch Buckle Closure Apron, Product Number A-10, Part Numbers recall — FDA Z-2107-2019
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
Class IIFDA: TerminatedBurlington Medical, LLC
Medical DeviceAug 7, 2019
Burlington Medical Thyroid Collar, Velcro Closure, Product Number TS2, Part Numbers RBTS2-R recall — FDA Z-2121-2019
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
Class IIFDA: TerminatedBurlington Medical, LLC
Medical DeviceAug 7, 2019
Burlington Medical 1 pc Full Wrap Support Belt Apron, Product Number F111, Part Numbers recall — FDA Z-2111-2019
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
Class IIFDA: TerminatedBurlington Medical, LLC
Medical DeviceAug 7, 2019
Ralston Group Maximum Pelvic Trainer (MPT) recall — FDA Z-2087-2019
The device was incorrectly listed with the FDA and is therefore considered adulterated and misbranded if left on the market. Additionally, the firm did not submit a 510k for the device.
Class IIFDA: TerminatedRalston Group
Medical DeviceAug 7, 2019
Burlington Medical Peak Vest, Single Item, Product Number PVest, Part Numbers REPVEST*M recall — FDA Z-2117-2019
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter…
Class IIFDA: TerminatedBurlington Medical, 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.