The Recall Desk

Archive

May 2022 recalls

426 recalls were announced in May 2022.

What the numbers show

Critical
12
Severe
68
High
275
Moderate
69
Low
2

Of the 426 recalls this month scored against our rubric, 3% are Critical, 16% are Severe.

Which agencies issued them

401–426 of 426

  • HighFDA (Drugs)·D-0821-2022·2022-05-04

    Compounded Injection Recalled Due to Manufacturing Process Monitoring Deviations

    Olympia Compounding Pharmacy recalled Formula F2 injectable (257 vials) due to improper investigation of manufacturing monitoring excursions before October 1, 2021. The product was distributed nationwide.

    Product
    Formula F2, Papaverine 9 mg/mL . Phentolamine 1 mg/mL . Alprostadil 10 mcg/mL . Atropine 0.1 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0002-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1020-2022·2022-05-04

    Elegant Foods Lemon Sorbet Recall: Undeclared Milk Allergen

    Elegant Foods is recalling Lemon Sorbet from Wisconsin due to undeclared whey protein concentrate, a milk allergen, in the product stabilizer. Consumers with milk allergies should not consume this product.

    Product
    elegant foods Lemon Sorbet, Plant #55-433, 537 Atlas Avenue, Madison, WI 53711.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1019-2022·2022-05-04

    elegant foods Chocolate Sorbet recalled for undeclared milk allergen

    Elegant Foods recalls chocolate sorbet products due to undeclared milk allergen in the stabilizer. Consumers with milk allergies may experience allergic reactions.

    Product
    elegant foods Chocolate Sorbet, Plant #55-433, 537 Atlas Avenue, Madison, WI 53711.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1006-2022·2022-05-04

    IV Start Kit convenience kits recalled for manufacturing validation defect

    ROi CPS LLC recalled 950 IV Start Kit convenience kits due to potential inadequacy in manufacturing test method validation. No injuries reported.

    Product
    Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0792-2022·2022-05-04

    Drug Recall: Zonisamide Capsules Due to Manufacturing Deviations

    Glenmark Pharmaceuticals is recalling 12,003 bottles of Zonisamide 50 mg capsules nationwide due to manufacturing deviations.

    Product
    ZONISAMIDE — ZONISAMIDE (ZONISAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0790-2022·2022-05-04

    Cyanocobalamin Injection Recalled Due to Subpotency and Assay Non-Compliance

    American Health Packaging is recalling Cyanocobalamin Injection because the product contains insufficient active ingredient and is out of specification for assay. The recalled lots (CCC210008, CCC210009) were distributed in Alabama.

    Product
    Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials, Rx only, Manufactured by: Eugia Pharma Specialties Limited, Hyderabad India for BluePoint Laboratories. NDC for Carton: 68001-509-60; NDC for vial: 68001-509-59
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0787-2022·2022-05-04

    Cough Medicine Recall: Undeclared Alcohol in Wal-Tussin DM

    Wal-Tussin DM cough medicine is being recalled because the product contains alcohol that was not declared on the label. Approximately 40,000–50,000 bottles distributed in Illinois are affected.

    Product
    Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0324-28.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0823-2022·2022-05-04

    Testosterone Cypionate Recalled Due to Manufacturing Quality Control Deviations

    Olympia Compounding Pharmacy is recalling Testosterone Cypionate 200 mg/mL due to failure to properly investigate manufacturing process monitoring deviations that occurred before October 2021. The recall affects 7,161 vials distributed nationwide.

    Product
    Testosterone Cypionate 200 mg/mL (in Grapeseed Oil), Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0054-10; b) 5 mL Multi-Dose vial, NDC 73198-0054-05, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0825-2022·2022-05-04

    Ultratest testosterone injection recalled for manufacturing monitoring deviations

    Olympia Compounding Pharmacy recalled 1,276 vials of Ultratest testosterone injection nationwide. Prior to October 2021, the manufacturer failed to properly investigate environmental and personnel monitoring deviations per FDA manufacturing standards.

    Product
    Ultratest, Testosterone Cypionate 160 mg/mL, Testosterone Propionate 40 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0058-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0827-2022·2022-05-04

    Sincalide Injectable Vials Recalled for Manufacturing Monitoring Failures

    Olympia Compounding Pharmacy is recalling 1,770 vials of Sincalide due to CGMP deviations in environmental and personnel monitoring. The manufacturer failed to properly investigate monitoring excursions prior to October 2021.

    Product
    Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0082-00.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1012-2022·2022-05-04

    Align Digestive De-Stress Capsules Recalled for Failed Microbiological Testing

    The Procter & Gamble Company is recalling Align Digestive De-Stress Capsules due to failure to meet microbiological specifications. Approximately 23,928 cartons were intended for destruction but were redirected for online sale instead.

    Product
    Align Digestive De-Stress Capsules 21ct bottle packaged in paper carton 12 cartons per case
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0817-2022·2022-05-04

    PGE-1 Alprostadil Injection Recalled for Manufacturing Process Deviations

    Olympia Compounding Pharmacy is recalling 821 vials of PGE-1 Alprostadil 40 mcg/mL injection nationwide. The recall is due to Current Good Manufacturing Practice deviations in environmental and personnel monitoring procedures that were not properly investigated.

    Product
    PGE-1, Alprostadil 40 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0028-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0818-2022·2022-05-04

    Alprostadil Injectable Drug Recalled for Manufacturing Quality Control Deviations

    Olympia Compounding Pharmacy is recalling 460 vials of Alprostadil 80 mcg/mL due to manufacturing quality control deviations related to improper investigation of environmental and personnel monitoring excursions prior to October 2021.

    Product
    PGE-2, Alprostadil 80 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0029-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1004-2022·2022-05-04

    IV Start Kit Convenience Kits Recalled for Manufacturing Test Validation Issue

    ROi CPS LLC is recalling 290 convenience kits containing IV Start Kits due to potential inadequacy in the validation of test methods used during manufacturing. Distribution was in Missouri.

    Product
    Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015, LD00199O - C Section Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830014016, LD00199P - C Section Mother.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0820-2022·2022-05-04

    Olympia Compounding Pharmacy recalls T-50 injectable medication for manufacturing quality control deviations

    Olympia Compounding Pharmacy is recalling T-50 injectable medication nationwide due to manufacturing quality control failures. Environmental and personnel monitoring controls were not properly investigated prior to October 2021.

    Product
    T-50, Papaverine 8 mg/mL . Phentolamine 0.29 mg/mL . Alprostadil 2.9 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0022-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·013-2022·2022-05-03

    Safeway Recalls Chicken Caesar Salad Due to Undeclared Allergens

    Safeway Fresh Food is recalling ready-to-eat Chicken Caesar Salad because the label fails to list anchovies, egg, and wheat. No illnesses have been reported.

    Product
    Safeway Fresh Food, LLC — Safeway Fresh Food, LLC Recalls Ready-To-Eat Salad Containing Chicken Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    6 states
  • SevereNHTSA·22V295000·2022-05-03

    2022-2023 Mack Granite Trucks Recalled for Insufficient Brake Air Tank Volume

    Mack is recalling 2022-2023 Granite trucks because the air tanks lack sufficient volume for proper brake system operation. Insufficient air can reduce braking performance and increase crash risk. Dealers will install replacement air tanks at no charge.

    Product
    MACK — MACK GRANITE (GR)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V293000·2022-05-03

    Cruiser Shadow Cruiser Travel Trailer Recall for LP Gas Leak Risk

    Cruiser RV is recalling 2022 Shadow Cruiser travel trailers because cracked LP gas fittings may cause a gas leak, increasing fire risk.

    Product
    CRUISER RV — CRUISER RV SHADOW CRUISER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V292000·2022-05-03

    2022 DRV Mobile Suites and Full House Recreational Vehicles LP Gas Leak Recall

    DRV is recalling 88 model-year 2022 Mobile Suites and Full House fifth wheel recreational vehicles with cracked quick disconnect fittings in the LP gas system. The defect may cause gas leaks that could increase the risk of fire.

    Product
    DRV — DRV MOBILE SUITES, FULL HOUSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V296000·2022-05-03

    2022 Tesla Model 3 Infotainment CPU Failure Risk During Fast Charging

    Tesla is recalling 2022 Model 3 vehicles where the infotainment CPU may overheat during fast charging, causing the center display to lag or restart, potentially preventing critical safety information from displaying.

    Product
    TESLA — TESLA MODEL S, MODEL X, MODEL Y, MODEL 3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V290000·2022-05-03

    Jayco and Entegra Recreational Vehicles Power Steering Line Defect

    Certain 2021-2022 Jayco and Entegra recreational vehicles have a defective power steering line connection that could result in sudden loss of power steering and brake assist, increasing crash risk. Dealers will replace the lines at no cost.

    Product
    JAYCO — JAYCO, ENTEGRA GREYHAWK, REDHAWK, ESTEEM, GREYHAWK PRESTIGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V289000·2022-05-02

    KZRV Travel Trailers Recalled for Cracked LP Gas Fittings

    KZRV recreational trailers and fifth wheels may have cracked LP gas fittings that can leak, creating a fire hazard. Dealers will replace fittings free of charge.

    Product
    KZRV — KZRV CONFLUENCE, DURANGO, DURANGO GOLD, ESCAPE
    Category
    Vehicle
    Distribution
    Distributed nationwide

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