Potato buns, in unlabeled clear plastic bags, 30 or 12 buns per bag.
Kansas City LLC.
🍎 Food Class I - Dangerous
Positive environmental samples analyzed for Listeria and Salmonella species.
All Recalls
95,018 total recalls in our database
Picket Fence Creamery, Woodward, IA, Key Lime Pie! ice cream, in quarts, pints and 1/2 pints
Picket Fence Creamery L.L.C.
🍎 Food Class I - Dangerous
Undeclared wheat, no gluten free labeling, and soy lecithin.
🍎 Food Class I - Dangerous
Positive environmental samples analyzed for Listeria and Salmonella species.
Hamburger buns, customer specified formula, in unlabeled clear plastic bags, 30 or 12 buns per bag.
Kansas City LLC.
🍎 Food Class I - Dangerous
Positive environmental samples analyzed for Listeria and Salmonella species.
Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx only
Lupin Pharmaceuticals
💊 Drugs Class I - Dangerous
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only
Lupin Pharmaceuticals
💊 Drugs Class I - Dangerous
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only
Lupin Pharmaceuticals
💊 Drugs Class I - Dangerous
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
💊 Drugs Class I - Dangerous
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
💊 Drugs Class I - Dangerous
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only
Lupin Pharmaceuticals
💊 Drugs Class I - Dangerous
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
💊 Drugs Class I - Dangerous
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
💊 Drugs Class I - Dangerous
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
💊 Drugs Class I - Dangerous
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
💊 Drugs Class I - Dangerous
Presence of Particulate Matter: Identified as Glass Particles
Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (NDC 7133517957) bottles, Rx only, Prinston Laboratories, Packaged by Bryant Ranch Prepack Burbank, CA 91504
Bryant Ranch Prepack, Inc.
💊 Drugs Class I - Dangerous
Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx only
Lupin Pharmaceuticals
💊 Drugs Class I - Dangerous
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
🏥 Medical Devices Class I - Dangerous
Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified until the device is placed in the patient and viewed under fluoroscopy, leading to increased procedural time.
FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
Karl Storz Endoscopy
🏥 Medical Devices Class I - Dangerous
During a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There is a risk that the patient may be exposed to a higher risk of infection.
🏥 Medical Devices Class I - Dangerous
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
GM Helix Acqua Implant 3.5x10, Article No. 140.944
Jjgc Industria E Comercio De Materials Dentarios Sa
🏥 Medical Devices Class I - Dangerous
3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low and the bone ridge has a maximum indication for the implant height (10mm), if the incorrect implant is installed, it could result in damage to the nerve or adjacent bone structures/cavities.