February 2022 recalls

666 recalls were announced in February 2022.

What the numbers show

Critical: 14
Severe: 237
High: 233
Moderate: 176
Low: 6

Of the 666 recalls this month scored against our rubric, 2% are Critical, 36% are Severe.

Which agencies issued them

301–400 of 666

ModerateFDA (Drugs)·D-0527-2022·2022-02-16
Dologen 325 Caplet Recalled for CGMP Deviations
ULTRAtab Laboratories, Inc. has voluntarily recalled Dologen 325 Caplet bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 917,304 tablets that were distributed to three distributors.
Product
Dologen 325 Caplet (Acetaminophen 325 mg, Dexbrompheniramine Maleate 1.0 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-121-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0533-2022·2022-02-16
Drug Recall: Normed APAP 325 mg Acetaminophen Bulk Tablets
ULTRAtab Laboratories is voluntarily recalling Normed APAP 325 mg acetaminophen bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 3.7 million tablets distributed to three distributors.
Product
Normed APAP 325 mg (Acetaminophen 325 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-203-00
Category
Drug
Distribution
0 states
ModerateFDA (Food)·F-0640-2022·2022-02-16
Natural Way Cheese Dill Cheese Curds Recalled for Improper Milk Storage
Natural Way Cheese is recalling Dill Cheese Curds because milk was stored in a holding tank longer than the required 72-hour cleaning interval. The improper storage creates a potential food safety risk.
Product
Natural Way Cheese Dill Cheese Curds, retail 12oz plastic bag UPC 8 10056 75019 0, 12 retail units per wholesale case
Category
Food
Distribution
2 states
ModerateFDA (Drugs)·D-0529-2022·2022-02-16
APAP 325 mg/Phenylephrine HCl 5 mg Tablets Bulk Container Recall
ULTRAtab Laboratories is recalling approximately 451,123 APAP 325 mg/Phenylephrine HCl 5 mg tablets in bulk containers due to CGMP deviations. The product was distributed to three distributors for further distribution as finished goods.
Product
APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-135-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0528-2022·2022-02-16
Drug Recall: Acetaminophen Phenylephrine Tablets for CGMP Deviations
ULTRAtab Laboratories is recalling Coated APAP 325 mg Phenylephrine HCl 5 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects bulk product distributed to three distributors.
Product
Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-134-00
Category
Drug
Distribution
0 states
ModerateFDA (Food)·F-0727-2022·2022-02-16
Dietary supplement melatonin recall due to manufacturing deviations
ULTRAtab Laboratories is recalling melatonin ER 2 mg caplets due to manufacturing process deviations. The recall affects 5.8 million tablets distributed to wholesalers.
Product
Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
Category
Food
Distribution
2 states
ModerateFDA (Food)·F-0729-2022·2022-02-16
Melatonin supplement MidNite Tablet recalled for manufacturing deviations
ULTRAtab Laboratories voluntarily recalled MidNite Tablet melatonin supplements due to manufacturing practice deviations. The recall encompasses 42,352,387 tablets distributed in bulk to two distributors in New York and Florida.
Product
MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NY
Category
Food
Distribution
2 states
ModerateFDA (Drugs)·D-0541-2022·2022-02-16
Trial Antacid Tablet bulk containers recalled for CGMP deviations
ULTRAtab Laboratories is recalling Trial Antacid Tablet bulk containers (Calcium Carbonate 420 mg) due to CGMP deviations. The product was distributed to three distributors who may have distributed finished product.
Product
Trial Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-310-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0553-2022·2022-02-16
Drug Recall: Coated Back Relief Tablet CGMP Deviations
ULTRAtab Laboratories, Inc. voluntarily recalls approximately 25.8 million tablets of Coated Back Relief Tablet due to current good manufacturing practice (CGMP) deviations detected during production.
Product
Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-800-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0539-2022·2022-02-16
Peppermint Antacid Tablets Recalled for CGMP Deviations
ULTRAtab Laboratories is recalling Peppermint Antacid tablets (Calcium Carbonate 420 mg) in bulk containers due to current good manufacturing practice (CGMP) deviations. The recall was initiated voluntarily by the manufacturer.
Product
Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-303-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0530-2022·2022-02-16
Drug Recall: APAP 500 mg Phenyl HCl Tablets for CGMP Deviations
ULTRAtab Laboratories is recalling approximately 14.3 million tablets of APAP 500 mg Phenyl HCl 5 mg tablets due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing.
Product
APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-140-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0551-2022·2022-02-16
Back Relief II Drug Recalled for CGMP Deviations
ULTRAtab Laboratories is recalling Back Relief II tablets due to Current Good Manufacturing Practice (CGMP) deviations. The firm initiated the voluntary recall of approximately 1.48 million tablets.
Product
Back Relief II (Acetaminophen 200 mg, Magnesium Salicylate 200 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-740-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0543-2022·2022-02-16
Nutralox Peppermint Antacid Bulk Container Recalled for CGMP Deviations
ULTRAtab Laboratories, Inc. is recalling approximately 5.9 million tablets of Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) bulk container due to Current Good Manufacturing Practice (CGMP) deviations.
Product
Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-312-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0535-2022·2022-02-16
Extra-Strength Unaspirin Caplet Recalled for CGMP Deviations
ULTRAtab Laboratories is recalling Extra-Strength Unaspirin caplets (Acetaminophen 500 mg) in bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects approximately 6.2 million tablets distributed to three distributors.
Product
Extra-Strength Unaspirin caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-207-00
Category
Drug
Distribution
0 states
ModerateFDA (Food)·F-0728-2022·2022-02-16
Melatonin ER supplement recalled for manufacturing practice deviations
ULTRAtab Laboratories voluntarily recalled Melatonin ER 5 mg caplets due to manufacturing deviations. The bulk product distributed to wholesalers in New York and Florida may have been repackaged and resold.
Product
Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
Category
Food
Distribution
2 states
ModerateCPSC·22085·2022-02-16
Anecdote Autumn Glass Candles recalled for fire and laceration hazards
Anecdote Candles is recalling approximately 19,380 Autumn Glass Candles sold at Anthropologie because the double-wick candles can produce higher-than-normal flames, causing the glass container to break and posing fire and laceration hazards.
Product
Anecdote Autumn Glass Candles
Category
Consumer Product
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0637-2022·2022-02-16
LYSO Disk microorganism culture device mislabeled with incorrect strain
Microbiologics' LYSO Disk culture disks labeled as containing Actinomyces odontolyticus have been found to actually contain Eggerthella lenta. The mislabeling affects products distributed to Canada and Germany.
Product
LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and contains a desiccant to prevent adverse moisture accumulation. A LYFO Disk" catalog
Category
Medical Device
Distribution
0 states
ModerateFDA (Drugs)·D-0534-2022·2022-02-16
Drug Recall: Coated APAP 500 mg Caplets for CGMP Deviations
ULTRAtab Laboratories, Inc. is recalling approximately 2 million Coated APAP 500 mg caplets due to current Good Manufacturing Practice (CGMP) deviations. The bulk product was distributed to three distributors who may have distributed finished product.
Product
Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-206-00
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0549-2022·2022-02-16
Normed Fem Tablet Recalled Due to CGMP Deviations
ULTRAtab Laboratories, Inc. is recalling Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The bulk product was distributed to 3 distributors who may have distributed finished product.
Product
Normed Fem Tablet (Acetaminophen 325 mg, Pamabrom 25 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-701-00
Category
Drug
Distribution
0 states
LowFDA (Devices)·Z-0581-2022·2022-02-16
Medical device lot number misprinted on packaging
Microbiologics Inc recalls KWIK-STIK 2 Pack Clostridium perfringens reference material (lot 318-234-4) because the foil pouch shows incorrect lot number 218-234-4. The correct number is on the device label.
Product
KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
Category
Medical Device
Distribution
0 states
HighNHTSA·22V080000·2022-02-15
Land Rover Recalls 2020 Range Rover Evoque for SRS Warning Light Software Defect
Jaguar Land Rover is recalling 2020 Range Rover Evoque vehicles because incorrect software may cause the airbag warning light to malfunction, potentially masking actual system failures.
Product
LAND ROVER — LAND ROVER RANGE ROVER EVOQUE
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22E007000·2022-02-14
Weldon recalls rear combination lamps with incorrect white backup lights
Weldon is recalling specific rear combination lamps because the LED backup lights are the wrong color, failing federal safety standards and potentially affecting vehicle visibility.
Product
EXTERIOR LIGHTING:BACK UP LIGHTS recall
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22E008000·2022-02-14
Intermotive Recalls Programmable Relay Power Center Modules for Fire Risk
Intermotive is recalling 514 Programmable Relay Power Center modules because exposed copper may cause short-circuits, increasing the risk of a fire.
Product
ELECTRICAL SYSTEM:WIRING:RELAYS/SOLENOIDS recall
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·22V077000·2022-02-11
Chrysler Recalls 2017-2018 Pacifica Plug-In Hybrids for Fire Risk
Chrysler is recalling 2017-2018 Pacifica Plug-In Hybrid vehicles because a fire can occur while parked. Owners should park outside and avoid recharging until repairs are completed.
Product
CHRYSLER — CHRYSLER PACIFICA PLUG-IN HYBRID
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V079000·2022-02-11
Autocar Recalls 2020-2022 Legend Vehicles Due to Grille Bezel Defect
Autocar is recalling 2020-2022 Legend vehicles because the grille bezel may detach, creating a road hazard and increasing crash risk.
Product
AUTOCAR — AUTOCAR LEGEND
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V078000·2022-02-11
Mercedes-Benz Recalls 2021 GLB 250 Vehicles for Front Air Bag Defect
Mercedes-Benz is recalling 2021 GLB 250 vehicles because an incorrect front driver's air bag module may not restrain occupants or could detach during a crash.
Product
MERCEDES-BENZ — MERCEDES-BENZ GLB 250
Category
Vehicle
Distribution
Distributed nationwide
HighUSDA FSIS·004-2022·2022-02-11
Great American Cobbler Recalls Chicken Pot Pie for Undeclared Soy Allergen
Great American Cobbler LLC is recalling Creole Style Chicken Pot Pie products because they contain soy, a known allergen, that is not declared on the label.
Product
Great American Cobbler Company LLC — Great American Cobbler Company, LLC, Recalls Creole Style Chicken Pot Pie Products Due to Misbranding and an Undeclared Allergen
Category
Food
Distribution
3 states
HighNHTSA·22V076000·2022-02-10
2022 Thor Motor Coach Motorhomes Rear Ladder Installation Defect Recall
Thor Motor Coach is recalling 2022 ACE, Freedom Traveler, Hurricane, and Windsport motorhomes. The rear ladder may have been installed on the wrong side, which could break while in use and cause injury.
Product
THOR MOTOR COACH — THOR MOTOR COACH ACE, FREEDOM TRAVELER, HURRICANE, WINDSPORT
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·22722·2022-02-10
Serta Perfect Sleeper Mattresses Recalled for Fire Hazard
Serta is recalling about 800 Perfect Sleeper mattresses because they fail to meet federal flammability standards, creating a fire hazard. No injuries have been reported.
Product
Serta® Perfect Sleeper® Mattresses
Category
Consumer Product
Distribution
Distributed nationwide
HighCPSC·22721·2022-02-10
2022 Can-Am Outlander ATVs Recalled Due to Speedometer Crash Hazard
BRP U.S. Inc. is recalling about 1,300 2022 Can-Am Outlander ATVs because the speedometer can display half the vehicle's true speed, creating a crash hazard. Consumers should stop using the vehicles and contact a Can-Am dealer for a free repair.
Product
2022 Can-Am Outlander ATVs
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·22078·2022-02-10
WORX 13 Amp 1900 PSI Electric Pressure Washers Recalled for Hose Separation
Positec USA is recalling about 17,630 WORX Brand 13 Amp 1900 PSI Electric Pressure Washers because the sprayer hose can separate from the spray wand during use, posing an impact injury hazard. Four minor injuries including cuts and bruises have been reported.
Product
WORX® Brand 13 Amp 1900 PSI Electric Pressure Washers
Category
Consumer Product
Distribution
Distributed nationwide
ModerateCPSC·22723·2022-02-10
Shop LC Electric Space Heaters Recalled Due to Fire and Burn Hazards
Shop LC is recalling about 4,500 personal electric space heaters that can overheat, posing fire and burn hazards. Consumers should stop using them immediately and return the product for a refund.
Product
Personal Electric Space Heaters
Category
Consumer Product
Distribution
Distributed nationwide
ModerateCPSC·22720·2022-02-10
Ski-Doo 2022 Snowmobiles Recalled Due to Speedometer Crash Hazard
BRP is recalling approximately 400 Ski-Doo 2022 snowmobiles because the speedometer may display half the vehicle's true speed, creating a crash hazard. Consumers should stop using the recalled snowmobiles and contact a Ski-Doo dealer for free repair.
Product
Ski-Doo Snowmobiles
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0481-2022·2022-02-09
COVID-19 Test Kits Recalled for Unauthorized FDA Marketing and Sale
Empowered Diagnostics LLC recalled COVID-19 test kits (ImmunoPass, NAB 900-60) sold nationwide without FDA approval. Approximately 2,100 units were distributed without required marketing clearance or authorization.
Product
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0463-2022·2022-02-09
Medroxyprogesterone Acetate Injection Recalled for Sterility Assurance
Ideal Specialty Apothecary is recalling Medroxyprogesterone Acetate Injection due to lack of assurance of sterility. The recall affects approximately 57,994 vials distributed nationwide.
Product
Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single Dose Vial, RX Only, Ideal Pharmacy, 2333 Morris Ave, Union, NJ 07083
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0480-2022·2022-02-09
COVID-19 Rapid Antigen Test Kit Distributed Without FDA Approval
CovClear COVID-19 Rapid Antigen Test kits (284,575 units) were distributed nationwide without FDA marketing approval, clearance, or authorization. All lots are recalled.
Product
CovClear COVID-19 Rapid Antigen Test, ATG 900-031
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0529-2022·2022-02-09
Baxter Spectrum IQ Infusion Pumps Recalled Due to Potential Medication Delivery Failure
Baxter Healthcare is recalling 241,304 Spectrum IQ infusion pumps due to potential medication delivery failure without user alert. The issue may occur during administration set setup or when occlusion alarms are not fully resolved.
Product
Baxter Spectrum IQ Infusion Pumps, Product code 3570009.
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·22V071000·2022-02-09
Altec Recalls 2018-2021 Aerial Devices and Digger Derricks for Structural Defect
Altec is recalling 2018-2021 Aerial Devices and Digger Derricks because cracks in the subbase bulkhead plate can cause shear plate failure, increasing the risk of injury.
Product
ALTEC — ALTEC DIGGER DERRICK, AERIAL DEVICE
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0530-2022·2022-02-09
Baxter SIGMA Spectrum infusion pumps recalled for medication delivery failures
Baxter is recalling 146,502 SIGMA Spectrum infusion pumps due to potential medication delivery failures that may occur without alerting clinicians. The issue is linked to administration set setup and occlusion alarm resolution.
Product
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0550-2022·2022-02-09
OXY-1 System Console Experiences Power Interruption During Use
OXY-1 System consoles used during cardiac support procedures may experience power interruptions that disrupt patient therapy, potentially causing prolonged oxygen deprivation.
Product
OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Drive, E Drive, and Pole Mount. The disposable Pump Lung Unit PLU part number 001-0400-100 is sold separately and is not part of this recall.
Category
Medical Device
Distribution
7 states
HighFDA (Food)·F-0626-2022·2022-02-09
Walla Walla Cheese Company Mad Curds Recalled for Underpasteurized Milk
Walla Walla Cheese Company has recalled Mad Curds produced from underpasteurized milk. The product was distributed in Oregon and Washington.
Product
Walla Walla Cheese Company Mad Curds. Keep Refrigerated. Product is packaged in vacuum sealed zip lock bags - net wt. 5 lbs. and 10 oz.
Category
Food
Distribution
2 states
HighCPSC·22075·2022-02-09
Pittsburgh Automotive Pneumatic Roller Seats Recall Due to Fall Hazard
Harbor Freight Tools is recalling Pittsburgh Automotive pneumatic roller seats because the connection between the seat and post can break, causing users to fall. The company has received 96 reports of seat welds breaking, including 10 reports of minor injuries.
Product
Pittsburgh Automotive Pneumatic Roller Seats
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0557-2022·2022-02-09
Chameleon PTA Balloon Catheter difficult protector sleeve removal risk
The Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm has a protector sleeve that may be difficult to remove, potentially damaging the balloon and causing patient harm. Covidien is recalling 1,994 devices.
Product
Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; Cardiovascular. Product Numbers CH08-40-75GB and CH08-40-75US
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0554-2022·2022-02-09
HARDY DIAGNOSTICS CatScreen diagnostic kit recalled due to improper storage
HARDY DIAGNOSTICS CatScreen test kits (Model HADZ110) are recalled because units were stored in temperature-controlled settings instead of refrigeration. Improper storage may compromise product effectiveness.
Product
HARDY DIAGNOSTICS CatScreen, 25dsk/vial
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0547-2022·2022-02-09
Ultrasound System Software Calculation Error in Siemens ACUSON Sequoia
Software error in certain Siemens ACUSON Sequoia ultrasound systems causes measurement values to be overestimated, potentially resulting in patient misdiagnosis.
Product
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0540-2022·2022-02-09
DIXI Microdeep Depth Electrode sterile barrier packaging defect
DIXI Medical Microdeep Depth Electrodes are recalled due to potential deformation of the blister pack packaging that could compromise the sterile barrier. 345 units nationwide are affected.
Product
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length va
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·22076·2022-02-09
Escalade Sports Tennis Tables Recalled for Fall and Injury Hazards
Escalade Sports is recalling about 5,200 tennis tables sold at Target from September to November 2021 because the table can collapse when leaned against, posing a fall hazard. The company has received 78 reports of collapse, including four reports of minor injuries.
Product
Escalade Sports Tennis Tables
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0536-2022·2022-02-09
DIXI Microdeep Depth Electrode packaging deformation poses sterility risk
DIXI Medical USA is recalling 2,141 Microdeep Depth Electrodes nationwide due to potential deformation of the blister pack that could compromise the sterile barrier when devices are removed from their Tyvek bags.
Product
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length va
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0630-2022·2022-02-09
Wayfare Dairy Free Butter recalled for suspected mold growth
WayFare Health Foods is recalling Wayfare Dairy Free Butter Salted & Whipped (610 cases) for suspected mold growth. Affected products were distributed to food distributors and consumers online across multiple states.
Product
Wayfare Dairy Free Butter Salted & Whipped,
Category
Food
Distribution
10 states
HighCPSC·22072·2022-02-09
Petzl Scorpio Eashook Lanyards with Carabiners Recalled for Fall Risk
Petzl is recalling about 230 Scorpio Eashook Lanyards with Carabiners because the carabiner's automatic gate-closing system can malfunction, creating a risk of serious injury or death.
Product
Scorpio Eashook Lanyards with Carabiners
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·22V069000·2022-02-09
Seat belt pretensioners may explode in recalled 2021 Hyundai Accent vehicles
Hyundai recalls 2021 Accent vehicles due to defective seat belt pretensioners that may explode in a crash and project metal fragments, risking injury to occupants.
Product
HYUNDAI — HYUNDAI ACCENT
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-0629-2022·2022-02-09
Taste of Inspirations Creme Puffs Recalled Due to Metal Contamination
Taste of Inspirations Creme Puffs are being recalled due to the potential presence of metal pieces in the product. The contamination was discovered in the bakery palm oil silo used during production.
Product
taste of Inspirations CREME PUFFS Whipped Cream Filled Pastry NET WT 13.2 OZ (375g) 30ct UPC: 7 25439 99597 9, DISTRIBUTED BY: DZA BRANDS, LLC SALISBURY, NC 28247
Category
Food
Distribution
4 states
HighNHTSA·22V073000·2022-02-09
Mercedes-Benz Recalls 2021 Sprinter Vans for Incorrect Weight Labeling
Daimler Vans USA is recalling 2021 Mercedes-Benz Sprinter vans because the gross vehicle weight rating may be incorrectly stated on the tire and loading label.
Product
MERCEDES-BENZ — MERCEDES-BENZ SPRINTER 1500, SPRINTER 3500, SPRINTER 2500, SPRINTER 4500
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V074000·2022-02-09
Maintainer Recalls 2021-2022 Truck-Mounted Cranes Due to Fire Risk
Maintainer is recalling 2021-2022 truck-mounted cranes because an incorrectly installed guard may damage fuel hoses or cables, increasing fire risk.
Product
MAINTAINER — MAINTAINER CRANE W/ SERVICE BODY
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·22V070000·2022-02-09
2022 BMW X4 and Related Models Transmission Rollaway Risk Recall
BMW is recalling certain 2022 330i, 530i, X3, and X4 vehicles because the transmission mechatronics unit may not have been properly assembled, potentially causing an internal leak that could lead to vehicle rollaway and crash risk.
Product
BMW — BMW X4, X3, 330I, 530I
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Food)·F-0623-2022·2022-02-09
Abby's Bakery frozen bread dough recalled due to glass contamination risk
Abby's Bakery Homestyle White Bread Dough may contain glass fragments. The affected product (lots 21340-31 to 21340-36) should be discarded.
Product
Abbys Bakery Homestyle White Bread Dough. Product number 93596. Keep Frozen. 4-1 lb. loaves. Net Wt. 4 lbs. (1.81kg) UPC 40730-93596. Abby's Bakery, Wadena, MN 56482
Category
Food
Distribution
4 states
HighFDA (Food)·F-0627-2022·2022-02-09
Delizza Chocolate Cream Puffs Recalled for Metal Contamination
Delizza Belgian Mini Chocolate Cream Puffs are recalled due to small metal pieces found in the bakery's palm oil silo that could not be reliably detected by the manufacturer's metal detector system.
Product
Delizza BELGIAN MINI CHOCOLATE CREAM PUFFS NET WT. 14.1 oz (400g) 30 CREAM PUFFS PRODUCED IN THE US BY DELIZZA INCORPORATED 6610 CORPORATION PARKWAY, BATTLEBORO, NC 27809 UPC 6 76670 00402 2
Category
Food
Distribution
4 states
HighFDA (Devices)·Z-0537-2022·2022-02-09
DIXI Medical Microdeep Depth Electrode Packaging Defect Threatens Sterile Barrier
DIXI MEDICAL USA is recalling Microdeep Depth Electrodes due to potential packaging deformation that could compromise the sterile barrier. Approximately 2,720 units were distributed nationwide for use in brain recording and stimulation procedures.
Product
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length va
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0542-2022·2022-02-09
DIXI Medical Microdeep Depth Electrode packaging defect may compromise sterility
DIXI MEDICAL USA is recalling Microdeep Depth Electrodes due to potential deformation of the internal packaging (blister pack) that could compromise the sterile barrier. The recall affects 365 units distributed nationwide.
Product
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length va
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·22073·2022-02-09
Stack Em' Up Books Recalls Children's Stackable Toys for Excessive Lead Paint
Stack Em' Up Books is recalling Adam the Apple children's stackable toys because the surface paint contains lead levels that exceed the federal lead paint ban. Lead is toxic if ingested by young children and can cause adverse health effects.
Product
Adam the Apple™ Children's Stackable Toys
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0538-2022·2022-02-09
FDA Recalls DIXI Medical Microdeep Depth Electrodes Due to Packaging Defect
DIXI MEDICAL USA is recalling Microdeep Depth Electrodes nationwide due to potential internal packaging deformation that could compromise the device's sterile barrier.
Product
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length va
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0532-2022·2022-02-09
Vagus Nerve Stimulation Therapy Leads Recalled for Tubing Wall Defect
LivaNova's PerenniaDURA vagus nerve stimulation leads may have insufficient silicone tubing thickness due to a manufacturing issue. This could result in unintended stimulation delivery or loss of therapy if the tubing is breached.
Product
Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 303-30 PereniaDURA Lead (3.0 mm electrode inner diameter)
Category
Medical Device
Distribution
7 states
HighCPSC·22071·2022-02-09
Children's Nightgowns Recalled for Flammability Standards Violation
AllMeInGeld children's nightgowns fail to meet federal flammability standards for sleepwear, posing a burn injury risk. About 3,900 units were sold on Amazon.com from October 2017 through June 2021.
Product
Children's Nightgowns
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Food)·F-0624-2022·2022-02-09
Walla Walla Cheese Cheddar Curds recalled due to under-pasteurization
Walla Walla Cheese Company is recalling Cheddar Curds due to under-pasteurization of the milk used in production, which may not eliminate potentially harmful bacteria.
Product
Walla Walla Cheese Company Cheddar Curds. Keep Refrigerated. Product is packaged in vacuum sealed zip lock bags. Net wt. 5 lbs.
Category
Food
Distribution
2 states
HighFDA (Devices)·Z-0533-2022·2022-02-09
Spinal Fusion Implant Insert Recalled for Assembly Defect
XTANT Medical is recalling 24 units of the X060-0270 8mm Titanium Insert for the Axle Interspinous Fusion System due to a manufacturing defect that prevents proper assembly of crossbar plates. The defect could affect the device's function during spinal fusion procedures.
Product
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0552-2022·2022-02-09
Premier Rotaclone Medical Device Recalled Due to Improper Storage Conditions
Medline Industries is recalling 34 units of the Premier Rotaclone (Lot 696004N116) due to improper storage in temperature-controlled settings instead of required refrigeration. This may affect device performance or safety.
Product
Premier Rotaclone, Rx only
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0539-2022·2022-02-09
DIXI Medical Depth Electrodes recalled for potential sterile packaging defect
DIXI MEDICAL USA is recalling 461 Microdeep Depth Electrodes. The internal blister packaging may deform, potentially compromising the sterile barrier when removed from the protective Tyvek bag.
Product
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length va
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0549-2022·2022-02-09
Philips eCareManager versions recalled due to unapproved Sentry Score software
Philips is recalling certain versions of eCareManager software because the Sentry Score feature was not approved by FDA prior to distribution. Users should contact Philips for updated information.
Product
eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManager version 4.5.2, eCareManager version 4.6.0- a software tool intended for use by trained medical staff providing supplemental remote support to bedside care
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0541-2022·2022-02-09
DIXI Microdeep Depth Electrodes recalled for potential packaging deformation compromising sterility
DIXI MEDICAL USA is recalling 1792 Microdeep Depth Electrodes due to potential deformation of the internal blister pack that could compromise the sterile barrier when the device is removed from its Tyvek bag.
Product
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length va
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·22077·2022-02-09
Home Easy Geek Heat Personal Heaters Recalled for Fire Hazard
Home Easy is recalling about 3,000 Geek Heat DH-QN06 personal heaters because the toggle power switch can spark and cause a fire. The company has received three reports of fires caused by the switch, though no injuries or property damage have been reported.
Product
Personal Electric Heaters
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Food)·F-0628-2022·2022-02-09
Delizza Belgian Mini Cream Puffs Recalled Due to Metal Contamination
Poppies International is recalling Delizza Belgian Mini Cream Puffs due to metal fragments found in the palm oil silo. The metal was not consistently detected during production screening.
Product
Delizza BELGIAN MINI CREAM PUFFS WHIPPED FILLING MADE WITH FRESH CREAM NET WT 13.2 oz (375g) PRODUCED IN THE US BY DELIZZA INCORPORATED 6610 CORPORATION PARKWAY, BATTLEBORO, NC 27809 UPC: 6 76670 00107 6, and NET WT. 3lb 5 oz. (1.5kg) 120ct UPC: 6 76670 00800 6
Category
Food
Distribution
4 states
HighFDA (Devices)·Z-0534-2022·2022-02-09
Microdeep Depth Brain Electrodes recall due to sterile barrier compromise risk
DIXI Medical is recalling 484 Microdeep Depth Electrodes nationwide due to potential deformation of internal packaging that could compromise the sterile barrier of these brain recording devices.
Product
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length va
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0556-2022·2022-02-09
Pelvic floor repair device may lack required packaging component
FEMSelect Ltd is recalling 141 units of the EnPlace trans-vaginal pelvic floor repair system because certain lots may not have been packaged with the required Channel Tube Limiter accessory.
Product
The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity. The anchors are pre-loaded inside the device shaft and are ready for use. A thimble is also supplied, as an accessory for the
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0535-2022·2022-02-09
DIXI Medical Microdeep Depth Electrode Sterile Barrier Compromise Recall
DIXI MEDICAL USA is recalling Microdeep Depth Electrodes used in neurological monitoring and stimulation due to potential deformation of the internal sterile packaging. The compromised sterile barrier could allow contamination before use.
Product
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length va
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0548-2022·2022-02-09
INTEGRA SURFIX ALPHA Torx 10 Screwdriver Out of Specification Recalled
Smith & Nephew recalls INTEGRA SURFIX ALPHA Screwdriver Torx 10 units because they are out of specification and may not mate properly with the Surfix Alpha Lock screw.
Product
INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0553-2022·2022-02-09
ARIES HSV 1&2 Diagnostic Cassettes May Leak, Affecting Test Results
Luminex Corporation is recalling ARIES HSV 1&2 Assay cassettes (lot numbers AB3600A and AB3560A) due to a confirmed 0.9% leak rate. Leaking cassettes may cause incorrect or delayed test results.
Product
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0555-2022·2022-02-09
Young Dental Sterilization Indicator Labels May Contain Wrong Type
YOUNG DH Dry Heat Indicator Labels used in healthcare sterilization may contain TTS Indicator Labels instead. Healthcare providers should verify package contents before use to ensure proper sterilization monitoring.
Product
YOUNG DH Dry Heat Indicators, PRESSURE SENSITIVE LABELS with COLOR INDICATOR STRIP, REF 116312 Intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process
Category
Medical Device
Distribution
0 states
HighNHTSA·22V072000·2022-02-09
Altec Recalls 2019-2021 Aerial Devices Due to Bolt Failure Risk
Altec is recalling 2019-2021 ATTXX-M/P/S aerial devices because over-tightened bolts in the rotation bearing may break, risking separation of the pedestal and turntable.
Product
ALTEC — ALTEC AERIAL DEVICE
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0545-2022·2022-02-09
Cryptococcal Antigen Test Kits Recalled for Reduced Detection Specificity
Immuno-Mycologics recalls 411 Cryptococcal Antigen test kits (lots F1021035, F1021036) for reduced specificity (90% vs. 99%), which may cause false-positive results leading to unnecessary anti-fungal therapy.
Product
CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Detection of Cryptococcal Antigen in serum and CSF, REF CR2003, IVD, UDI: (01)00816387020919
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0625-2022·2022-02-09
Walla Walla Cheese Company Cheddar Curds Recalled for Under Pasteurization
Walla Walla Cheese Company is recalling AJ's Walla Walla Sweet Onion Mustard Cheddar Curds because the cheese was made from under pasteurized milk.
Product
Walla Walla Cheese Company AJ s Walla Walla Sweet Onion Mustard Cheddar Curds. Keep Refrigerated. Product is packaged in vacuum sealed zip lock bags. Net wt. 10 oz.
Category
Food
Distribution
2 states
ModerateFDA (Drugs)·D-0482-2022·2022-02-09
Backache & Muscle Relief Drug Recalled for cGMP Deviations
Ultra Seal Corporation is recalling Backache & Muscle Relief packets nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects approximately 5.1 million packets distributed across the United States.
Product
Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-111-832
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0497-2022·2022-02-09
Pain & Sinus Reliever tablets recalled for manufacturing deviations
Ultra Seal Corporation is recalling 887,000 packets of Pain & Sinus Reliever (acetaminophen/phenylephrine) tablets nationwide due to cGMP manufacturing deviations. The recalled product is identified by Lot #AK9527 with expiration date 03/2022.
Product
Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-194-68
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0506-2022·2022-02-09
MidNite Natural Sleep Aid Chewable Tablets Recalled for cGMP Deviations
Ultra Seal Corporation is recalling MidNite Natural sleep aid chewable tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects 90,072 bottles distributed across the United States.
Product
MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, BGP Pharma ULC, Etobicoke, ON M8Z 2S6
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0483-2022·2022-02-09
Drug Recall: Cold Relief Tablets Due to cGMP Deviations
Ultra Seal Corporation is voluntarily recalling Cold Relief tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The affected product is distributed nationwide in the United States.
Product
Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-112-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0502-2022·2022-02-09
Drug Recall: PEPTIME Energy Caffeine Tablets cGMP Violations
Ultra Seal Corporation is recalling PEPTIME Energy 300mg caffeine tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall affects 131,112 packets and 8,064 bottles distributed across the United States.
Product
PEPTIME Energy (caffeine 300mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0466-2022·2022-02-09
AERO TAB Cold Relief Drug Recalled for cGMP Deviations
Ultra Seal Corporation is recalling AERO TAB Cold Relief tablets nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 226,390 packets of the product distributed nationwide.
Product
AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0473-2022·2022-02-09
Ephedrine Plus tablets recalled for cGMP manufacturing deviations
Ultra Seal Corporation is recalling Ephedrine Plus tablets nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 301,842 bottles distributed across the United States.
Product
Ephedrine Plus (Ephedrine HCl 25mg, Guaifenesin 200mg) tablets, 24-count bottles, Marketed by: DMD Pharmaceuticals A Division of Dickery Consumer Products, Inc. Noblesville, IN 46060, NDC 65193-320-24
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0474-2022·2022-02-09
Drug Recall: Dologen Caplets for cGMP Manufacturing Deviations
Ultra Seal Corporation is recalling Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1 mg) caplets nationwide due to current Good Manufacturing Practice (cGMP) deviations during manufacture.
Product
Dologen (acetaminophen 325 mg and dexbrompheniramine maleate 1mg) caplets, packaged in a) 90-count bottles, b) 2-count packets, Manufactured in the USA for Kramer-Novis, San Juan, Puerto Rico 00917, NDC 52083-482-02
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0493-2022·2022-02-09
Drug Recall: PAINAID BRF Back Relief Formula cGMP Deviations
Ultra Seal Corporation is recalling PAINAID BRF Back Relief Formula tablets due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 111,300 packets distributed nationwide.
Product
PAINAID BRF Back Relief Formula (acetaminophen 250 mg, caffeine 50 mg, Magnesium salicylate 290 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0003-00
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0504-2022·2022-02-09
Drug Recall: PEPTIME Energy Tablets cGMP Deviations
Ultra Seal Corporation is voluntarily recalling PEPTIME Energy (caffeine 250mg) tablets distributed nationwide due to manufacturing practice deviations. The recall affects 156,096 packets and 9,648 bottles.
Product
PEPTIME Energy (caffeine 250mg) tablets, packaged in a) 6 count packets and b) 100-count bottles, Marketed by: DMD Pharmaceuticals, A Division of Dickery Consumer Products, Inc., Noblesville, IN 46060.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0478-2022·2022-02-09
Multi Symptom Cold Relief tablets recalled for cGMP deviations
Ultra Seal Corporation is voluntarily recalling 673,160 packets of Multi Symptom Cold Relief tablets distributed nationwide due to cGMP (current Good Manufacturing Practice) deviations.
Product
Multi Symptom Cold Relief (acetaminophen 325 mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0499-2022·2022-02-09
PAPENOL acetaminophen 500 mg packets recalled for cGMP deviations
Ultra Seal Corporation is recalling PAPENOL acetaminophen 500 mg (2 tablet packets) nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 533,100 packets with lot numbers K9495 (exp. 02/2022) and AK9614 (exp. 05/2022).
Product
PAPENOL (acetaminophen 500 mg), 2 tablet packets, Manufactured for: Afassco Inc. Minden, NV 89423
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0484-2022·2022-02-09
Drug Recall: Headache & Congestion Sinus Relief cGMP Deviations
Ultra Seal Corporation is recalling Headache & Congestion Sinus Relief tablets nationwide due to current good manufacturing practice (cGMP) deviations. This is a voluntary Class II recall affecting approximately 5.7 million packets.
Product
Headache & Congestion Sinus Relief (acetaminophen 250 mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-0206-02
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0488-2022·2022-02-09
Pain Terminator Extra Strength Pain Relief Drug Recall
Ultra Seal Corporation is recalling PAIN TERMINATOR extra strength pain relief packets nationwide due to cGMP (current Good Manufacturing Practice) deviations detected during manufacturing. The recall affects 1,188,280 packets of the product.
Product
PAIN TERMINATOR extra strength pain relief (aspirin 162 mg, acetaminophen 110 mg, Caffeine 32.4mg, Salicylamide 152 mg) 2 tablet packets, Manufactured for: Tellus Medical Products, Palm Desert, CA 92211, NDC 69103-2507
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0519-2022·2022-02-09
Sinus Relief Headache/Nasal Drug Recalled for cGMP Deviations
Ultra Seal Corporation is recalling Sinus Relief Headache/Nasal tablets (acetaminophen 325mg, phenylephrine HCl 5mg) nationwide due to current Good Manufacturing Practice (cGMP) deviations discovered during manufacturing.
Product
Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0470-2022·2022-02-09
Legatrin PM Pain Reliever/Sleep Aid Recalled for cGMP Deviations
Ultra Seal Corporation is recalling 174,852 bottles of Legatrin PM Pain Reliever/Sleep Aid nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall is voluntary and was initiated on January 24, 2022.
Product
Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg caplets) 50-count bottles, Manufactured for: Church & Dwight Co., Inc. Ewing, NJ 08628 NDC 10237-907-50
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0486-2022·2022-02-09
Cold/Sinus Medication Recalled for Manufacturing Process Violations
Ultra Seal Corporation is recalling 301,650 packets of a Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant due to cGMP deviations discovered during manufacturing. The product was distributed nationwide.
Product
Cold/Sinus Pain Reliever/Fever Reducer Nasal Decongestant (acetaminophen 325 mg, Phenylephrine HCl 5mg), 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0494-2022·2022-02-09
PAINAID PMF Premenstrual Formula Recalled for cGMP Deviations
Ultra Seal Corporation voluntarily recalled PAINAID PMF Premenstrual Formula packets nationwide due to cGMP (current Good Manufacturing Practice) deviations.
Product
PAINAID PMF Premenstrual Formula (acetaminophen 500 mg, pamabrom 25mg) 2 caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-0046-03
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0492-2022·2022-02-09
Drug Recall: PAINAID Tablets for Manufacturing Deviations
Ultra Seal Corporation is recalling approximately 2.3 million packets of PAINAID pain relief tablets nationwide due to cGMP (current Good Manufacturing Practice) deviations in manufacturing processes.
Product
PAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide 152mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0495-2022·2022-02-09
Drug Recall: CONGESTAID II Nasal Decongestant for Manufacturing Deviations
Ultra Seal Corporation is recalling CONGESTAID II Nasal Decongestant packets due to current Good Manufacturing Practice (cGMP) deviations. The voluntary nationwide recall affects 447,050 packets.
Product
CONGESTAID II Nasal Decongestant (Phenylephrine HCl 5mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040
Category
Drug
Distribution
Distributed nationwide

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