The Recall Desk

Archive

May 2023 recalls

754 recalls were announced in May 2023.

What the numbers show

Critical
15
Severe
133
High
527
Moderate
72
Low
7

Of the 754 recalls this month scored against our rubric, 2% are Critical, 18% are Severe.

Which agencies issued them

1–100 of 754

  • CriticalFDA (Food)·F-0925-2023·2023-05-31

    Lay's Potato Chips Recalled for Undeclared Milk Allergen

    Frito-Lay is recalling Lay's Classic Potato Chips due to undeclared milk. The recall affects specific products distributed in Connecticut, Massachusetts, Maine, and New Hampshire.

    Product
    Lay s Classic Party Size Potato Chips 13 oz. (368.5 g) UPC 028400310413 packaged in a yellow flexible bag and Lay s Classic Mix and Match Potato Chips 15 5/8 oz (442.9 g) UPC 0028400720151 packaged in a yellow flexible bag
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Devices)·Z-1618-2023·2023-05-31

    Pediatric Ventricular Assist Device Blood Pumps Recalled for Potential Membrane Disruption

    BERLIN HEART GMBH recalls EXCOR Pediatric Ventricular Assist Device Blood Pumps due to potential disruption in triple-layer membranes. The 335 affected units were distributed to multiple US states and Canada.

    Product
    EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50 ml blood pump); P60P-001 (60 ml blood pump). Recall occurred in 2018, and was…
    Category
    Medical Device
    Distribution
    16 states
  • SevereFDA (Food)·F-0929-2023·2023-05-31

    Washington Crab Crabcakes Recalled Due to Undeclared Allergens

    Washington Crab & Seafood Company recalls crabcakes due to undeclared allergens: egg, wheat, and soy. The product was distributed to North Carolina and South Carolina.

    Product
    CRABCAKE Ingredients: Blue Crabmeat, mayonnaise, onion bread crumbs, egg solids, salt, spices paprika WASHINGTON CRAB Carolina seafood
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0924-2023·2023-05-31

    Lancaster Spinach Recalled for Possible Listeria Contamination

    Lancaster Spinach, 10-ounce packages, is recalled due to possible contamination with Listeria monocytogenes. Products were distributed in Massachusetts, Maryland, Pennsylvania, New York, New Jersey, and Virginia.

    Product
    LANCASTER SPINACH, 10 OZ, UPC:8-13055-01145-3. Packaged in sealed plastic bags, 12 in a case.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1594-2023·2023-05-31

    COVID-19 At-Home Test Kits Recalled for Bacterial Buffer Contamination

    SD Biosensor is recalling 2,712,767 Pilot COVID-19 At-Home Test kits nationwide due to bacterial contamination in the liquid buffer component. Users may notice an odor from affected kits.

    Product
    Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0921-2023·2023-05-31

    Multiple kale greens products recalled for possible Listeria contamination

    Lancaster Foods LLC is recalling ROBINSON FRESH and LANCASTER kale greens products due to possible Listeria monocytogenes contamination. Affected products have a best-by date of May 1, 2023, and were distributed in MA, MD, PA, NY, NJ, and VA.

    Product
    ROBINSON FRESH KALE GREENS, NET WT 16 OZ, UPC:0-95829-60015. Packaged in sealed plastic bags, 8 in a case. ROBINSON FRESH KALE GREENS NET WT 32 OZ UPC: 0-95829-60016-6. Packaged in sealed plastic bags, 8 in a case. LANCASTER Chopped Kale NET WT 4 OZ CHOPPED KALE. Packaged in…
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0922-2023·2023-05-31

    Giant Curly Leaf Spinach Recalled for Possible Listeria Contamination

    Lancaster Foods LLC is recalling Giant Curly Leaf Spinach due to possible Listeria monocytogenes contamination. The product was distributed in MA, MD, PA, NY, NJ, and VA.

    Product
    GIANT CURLY LEAF SPINACH, 12 /8 OZ, UPC: 6-88267-09813-0. Packaged in sealed plastic bags, 12 in a case.
    Category
    Food
    Distribution
    6 states
  • SevereNHTSA·23V387000·2023-05-31

    Triple E Recalls 2023 Motorhomes Due to LPG Gas Leak Risk

    Triple E is recalling 2023 Unity and Wonder motorhomes because an improperly crimped 2-stage regulator may cause a gas leak, increasing the risk of fire.

    Product
    TRIPLE E RV — TRIPLE E RV, TRIPLE E WONDER, UNITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0923-2023·2023-05-31

    Collard Greens Recalled Due to Possible Listeria Contamination

    Lancaster Foods is recalling Robinson Fresh and Giant collard greens due to possible contamination with Listeria monocytogenes. Affected products distributed in the Northeast and Mid-Atlantic should not be consumed.

    Product
    ROBINSON FRESH COLLARD GREENS, 16 OZ, UPC:0-95829-60006-7. Packaged in sealed plastic bags, 8 in a case. GIANT COLLARD GREENS, 16 OZ, UPC: 6-88267-05311-5. Packaged in sealed plastic bags, 8 in a case.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0931-2023·2023-05-31

    Tuna Salad Cup Recalled Due to Undeclared Egg Allergen

    Ultra Tuna Salad Cup (DishD'Lish brand) distributed in Washington is recalled because the label does not declare egg as an ingredient. Consumers with egg allergies should not consume this product.

    Product
    Ultra Tuna Salad Cup, brand DishD'Lish, packaged in plastic cup. Label declares Housemade Albacore Tuna Salad, Arugula, Cucumber and Cherry Tomatoes.
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·23V388000·2023-05-31

    Bugatti Recalls One 2023 Chiron Super Sport for Incorrect Wheels

    Bugatti is recalling one 2023 Chiron Super Sport because incorrect wheels were installed, which may cause loss of vehicle control in Top Speed Mode.

    Product
    BUGATTI — BUGATTI CHIRON SUPER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0933-2023·2023-05-31

    House Made Tarragon Chicken Salad Sandwich—undeclared egg and wheat allergens

    FDA recalls House Made Tarragon Chicken Salad Sandwich by DishD'Lish because the label fails to declare egg and wheat, which are common allergens present in the product.

    Product
    House Made Tarragon Chicken Salad Sandwich, brand DishD'Lish. The label declares House Roasted Chicken Breast, Herbs, Fresh Tarragon, Arugula, Mayonnaise, and Whole Grain Bread.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0932-2023·2023-05-31

    Ultra Tuna Salad Sandwich recall: undeclared egg and wheat allergens

    Ultra Tuna Salad Sandwich sold in Washington contains undeclared egg and wheat allergens. The label fails to declare these common allergens, posing a risk to allergic consumers.

    Product
    Ultra Tuna Salad Sandwich, brand DishD'Lish. The label declares Albacore Tuna with Fresh Herbs, Mayo, Capers, Cucumbers, and pickles on Organic Whole Grain Bread. Served with Sweet Pickle Chips.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0928-2023·2023-05-31

    Cole Slaw Recalled Due to Undeclared Egg and Soy Allergens

    Washington Crab & Seafood Company recalls 463 cases of 16-ounce Cole Slaw sold in North Carolina and South Carolina. The product contains undeclared egg and soy allergens not listed on the label.

    Product
    COLE SLAW Ingredients: cabbage, mayonaise sugar, vinegar, celery seed, salt WT 16 oz WASHINGTON CRAB Carolina seafood
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0955-2023·2023-05-31

    Safeway Oatmeal Raisin Cookies Recalled for Undeclared Peanut and Soy Allergens

    Safeway brand Oatmeal Raisin Cookies (18 count) are being recalled due to undeclared peanut and soy allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    Oatmeal Raisin Cookies 18 Count, Safeway brand, packaged in a clear plastic hinged container, Net wt. 14oz. UPC 0 227862 70500 7. Distributed by Safeway Inc. Pleasanton, CA 94588. The Oatmeal Raisin scale label does include allergen advisory statement: Made in a facility that…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0755-2023·2023-05-31

    Injectable Drug Recalled for Unverified Sterility After FDA Inspection

    Central Admixture Pharmacy Services is recalling 1673 bags of HyperLyte CR Injection due to lack of sterility assurance. An FDA inspection raised questions about whether the product met sterility standards.

    Product
    HyperLyte CR Injection, 250 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-2, code 7128580942.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0702-2023·2023-05-31

    OxyTOCIN-dextrose injectable recalled nationwide for sterility assurance concerns

    Central Admixture Pharmacy Services is recalling oxyTOCIN 20 units in dextrose 5%/Lactated Ringer's solution nationwide due to lack of sterility assurance identified during FDA inspection. 7,595 bags across multiple lot numbers are affected.

    Product
    oxyTOCIN 20 units added to dextrose 5%/Lactated Ringer's 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6031-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0698-2023·2023-05-31

    FDA Recalls Neonatal Parenteral Nutrition Bags for Sterility Concerns

    Central Admixture Pharmacy Services recalled 328 neonatal parenteral nutrition bags nationwide due to FDA concerns about product sterility after an inspection.

    Product
    Neonatal PN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100 Allentown, PA 18106, NDC 71285-0429-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0901-2023·2023-05-31

    Country Cookie Oatmeal Scotchie Cookies Recalled for Undeclared Milk Allergen

    Country Cookie LLC. is recalling Oatmeal Scotchie cookies because milk is present in the product but not declared on the allergen statement. Consumers with milk allergies should not consume these products.

    Product
    Country Cookie Oatmeal Scotchie cookie, plastic wrapped
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0693-2023·2023-05-31

    FDA Recalls Neonatal TPN Starter Bags for Sterility Concerns

    Central Admixture Pharmacy Services recalls 747 bags of Neonatal TPN Starter Bags due to FDA sterility concerns. Products were distributed nationwide across the USA.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0422-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0953-2023·2023-05-31

    Ceramic Copitas Recalled Due to Potential Lead Leaching

    Pernod Ricard Usa Inc is recalling ceramic copitas (small cups) distributed by Del Maguey because they may exceed FDA guidance levels for leachable lead. The recall affects 177,000 units distributed nationwide since October 2022.

    Product
    Copitas; small ceramic cups; "Del Maguey" embossed on the bottom; distributed by Del Maguey
    Category
    Consumer Product
    Distribution
    37 states
  • HighFDA (Drugs)·D-0664-2023·2023-05-31

    Cardioplegia Solution Recalled Due to Sterility Assurance Issues

    Central Admixture Pharmacy Services is recalling Cardioplegia Solution (Induction 4:1 High Potassium) due to lack of sterility assurance following an FDA inspection. The recall affects 84 bags distributed nationwide.

    Product
    Cardioplegia Solution, Induction 4:1 High Potassium, 30 mEq K, packaged in 415 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0106-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0930-2023·2023-05-31

    Geisha Medium Shrimp Recalled Due to Under-Processing Risk

    Kawasho Foods USA recalls Geisha Medium Shrimp (4 oz) due to potential under-processing. Do not consume; discard or return to point of purchase.

    Product
    Geisha Medium Shrimp; WT 4OZ(113g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0725-2023·2023-05-31

    Vancomycin Sodium Chloride Injection Recalled Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling 11,338 bags of vancomycin sodium chloride injection nationwide due to FDA concerns about product sterility following an inspection.

    Product
    vancomycin added to 0.9% sodium chloride, 1.5 g/500 mL* (3 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6176-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0685-2023·2023-05-31

    Neonatal TPN Starter Bags Recalled for Sterility Assurance Issue

    Central Admixture Pharmacy Services recalls 138 bags of Neonatal TPN Starter Bag nationwide after FDA inspection questioned the products' sterility assurance. Affected lots expire between April and May 2023.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with CALCIUM, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0407-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0707-2023·2023-05-31

    Injectable Oxytocin Lactated Ringer's Solution Recalled for Sterility Concerns

    Central Admixture Pharmacy Services is recalling 21,871 bags of injectable oxytocin mixed with Lactated Ringer's solution nationwide due to sterility assurance failures identified during an FDA inspection.

    Product
    oxyTOCIN 30 units added to Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6039-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0914-2023·2023-05-31

    Country Cookie Chocolate Brownies Recalled for Undeclared Milk Allergen

    Country Cookie Chocolate Brownies sold in Missouri and Kansas are being recalled because they contain milk but the allergen is not declared on the label.

    Product
    Country Cookie Chocolate Brownie, plastic clamshell
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0716-2023·2023-05-31

    IV Potassium Phosphate Solution Recalled Due to Sterility Concerns

    Central Admixture Pharmacy Services recalls 9,432 bags of potassium phosphate injectable solution nationwide following FDA inspection findings that questioned the sterility of these pharmaceutical products.

    Product
    potassium phosphate 15 mmole added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6060-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·23V366000·2023-05-31

    Marion Body Works Recalls 2022-2023 Spartan Fire Trucks for Transmission Defect

    Marion Body Works is recalling 2022 Spartan Fire Gladiator and 2023 Spartan Fire MetroStar emergency vehicles because the transmission control module may fail to engage 4th gear lockup, preventing the water pump from starting.

    Product
    MARION BODY WORKS — MARION BODY WORKS SPARTAN FIRE METROSTAR, SPARTAN FIRE GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0951-2023·2023-05-31

    TruBoost Drink Ruby Rev recalled for unapproved dietary ingredients

    TruVision Health LLC is recalling TruBoost Drink - Ruby Rev because it contains DMHA and/or hordenine, which the FDA has determined are not acceptable dietary ingredients.

    Product
    TruBoost Drink - Ruby Rev
    Category
    Food
    Distribution
    50 states
  • HighFDA (Drugs)·D-0719-2023·2023-05-31

    Vancomycin Dextrose Injectable Recalled Due to Sterility Concerns

    Central Admixture Pharmacy Services is recalling 13,772 bags of vancomycin-dextrose injectable distributed nationwide after an FDA inspection questioned its sterility assurance. No illnesses have been reported.

    Product
    vancomycin added to dextrose 5%, 1.25 g/250 mL* (5 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6073-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0711-2023·2023-05-31

    Oxytocin Injectable Drug Recalled Over Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling 1,332 bags of oxytocin injectable solution due to FDA concerns about sterility assurance. The company could not confirm the product met sterility standards after an FDA inspection.

    Product
    oxyTOCIN 60 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6045-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1617-2023·2023-05-31

    Omnicell IVX Station medical device recalled for dose accuracy failures

    OmniCell recalls six Omnicell IVX Station devices used for automated pharmaceutical preparation. The devices may not account for scale inaccuracy, potentially allowing incorrect doses to pass quality checks.

    Product
    Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-0695-2023·2023-05-31

    Neonatal TPN Starter Bags Recalled for Unassured Sterility

    Central Admixture Pharmacy Services is recalling 135 bags of neonatal TPN starter bags distributed nationwide because the FDA found inadequate assurance of sterility during inspection.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0425-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0697-2023·2023-05-31

    Neonatal TPN Bags Recalled Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services recalled 485 bags of Neonatal TPN Starter Bag nationwide due to FDA concerns about manufacturing sterility assurance. No illnesses have been reported.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0428-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1626-2023·2023-05-31

    Diagnostic Cartridge Assay May Fail to Detect Chlamydia Trachomatis Correctly

    Binx Health is recalling a single lot of its CT/NG diagnostic cartridges distributed in Pennsylvania. The cartridges may not accurately detect Chlamydia trachomatis, potentially producing false negative or false positive results.

    Product
    binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0938-2023·2023-05-31

    Julie's Real JR Bar Granola Bars Recalled for Possible Metal Contamination

    Julie's Real JR Bar Cinnamon Vanilla Bean Grain-Free Granola Bars are being recalled due to possible presence of metal. The recall affects approximately 22,290 boxes distributed nationwide.

    Product
    Julie's Real JR Bar Cinnamon Vanilla Bean Grain-Free Granola Bar, Net Wt 1.4 oz (40g), UPC 857628006699, packaged and sold in a 6 Pack Box to consumers, sold as a Master Case of 6, 6 Pack Boxes to retailer and distributor
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1613-2023·2023-05-31

    Olympus Single Use Distal Cover for Endoscope Recalled Due to Detachment Risk

    Olympus is recalling about 309,278 single-use endoscope covers that may detach during use, risking aspiration, inhalation, obstruction, or burns.

    Product
    Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0670-2023·2023-05-31

    Cardioplegia Solution Recalled Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services, Inc. is recalling cardioplegia solution for lack of assurance of sterility. FDA inspection questioned the sterility of this injectable product; 241 bags were distributed nationwide.

    Product
    Cardioplegia Solution, Modified St Thomas Solution, HIGH POTASSIUM, HIGH SODIUM BICARBONATE, 106 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0204-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0681-2023·2023-05-31

    Cardiac Perfusion Solution Recalled for Sterility Assurance Issues

    Central Admixture Pharmacy Services is recalling Modified del Nido Microplegia syringes after an FDA inspection raised concerns about their sterility. Approximately 690 syringes distributed nationwide may be affected.

    Product
    Modified del Nido Microplegia, packaged in 40 mL per syringe, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0219-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0909-2023·2023-05-31

    Country Cookie Molasses Cookies Recalled for Undeclared Milk Allergen

    Country Cookie LLC is recalling molasses cookies due to undeclared milk allergen on the label. Consumers with milk allergies who consume this product face serious allergic reactions.

    Product
    Country Cookie Molasses cookie, plastic wrapped
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0754-2023·2023-05-31

    FDA Recalls HyperLyte CR Injection for Lack of Sterility Assurance

    The FDA recalled HyperLyte CR Injection because the manufacturer could not assure the product met sterility requirements. The recall affects 554 bags distributed nationwide.

    Product
    HyperLyte CR Injection, 500 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-1, code 7128580941.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0908-2023·2023-05-31

    Country Cookie M&M Cookies Recalled for Undeclared Milk Allergen

    Country Cookie LLC is recalling M&M cookies and mini cups distributed in Missouri and Kansas because the label does not declare milk as an allergen. Consumers allergic to milk should discard the recalled products.

    Product
    Country Cookie M&M cookie, plastic wrapped; Country Cookie Mini Cups of Cookies M&M Cookie
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0731-2023·2023-05-31

    Heparin Injection Recalled Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling heparin injectable solutions nationwide due to sterility concerns identified during an FDA inspection. Over 11,000 bags of the product are affected.

    Product
    heparin added to 0.9% sodium chloride, 4,000 units/1,000 mL* (4 units/mL), 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7022-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0708-2023·2023-05-31

    FDA Recalls Oxytocin Injection Bags Over Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 3,865 bags of oxytocin injection across the USA due to lack of sterility assurance identified during an FDA inspection. Sterile injectables must meet strict standards to prevent infection risk.

    Product
    oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 72185-6042-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0666-2023·2023-05-31

    Cardioplegia Solution Recalled Nationwide for Sterility Assurance Concerns

    Central Admixture Pharmacy Services recalls 613 bags of cardioplegia solution nationwide due to FDA inspection concerns about sterility assurance.

    Product
    Cardioplegia Solution, Induction 4:1 Plasma-Lyte/Tromethamine, High Potassium, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0111-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0686-2023·2023-05-31

    Neonatal TPN Starter Bags Recalled for Sterility Assurance Issues

    Central Admixture Pharmacy Services is recalling 167 bags of neonatal TPN Starter Bag due to FDA concerns about product sterility identified during inspection.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0408-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0674-2023·2023-05-31

    Cardioplegia Solution Recalled Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services recalls 208 bags of Cardioplegia Solution nationwide due to sterility assurance concerns identified during an FDA inspection.

    Product
    Cardioplegia Solution, Modified St Thomas Formula, low potassium, 70 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0210-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0679-2023·2023-05-31

    Cardioplegia Solution Recalled Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services recalls Cardioplegia Solution (325 bags nationwide) after FDA inspection identified loss of sterility assurance. Product is used in cardiac surgery and requires prescription.

    Product
    Cardioplegia Solution, Maintenance 8:1 non-enriched, low potassium, 24 mEq K, packaged in 300 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0215-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0895-2023·2023-05-31

    The Traveler's Best sandwiches recalled for undeclared sesame allergen

    GH Foods LLC is recalling The Traveler's Best Ham & Swiss on Pretzel Roll sandwiches due to undeclared sesame seeds. Sesame is a major allergen; consumers with sesame allergies face serious health risks.

    Product
    The Traveler's Best Ham & Swiss on Pretzel Roll Smoked Ham and Swiss Cheese With Lettuce and Dijon Mustard on a Pretzel Roll Ingredients: Pretzel Bun (Enriched Wheat Flour (Wheat Flour, Malted Barley Flour, Niacin, Iron, Thiamin Mononitrate, Riboflavin, Folic Acid), Water…
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0950-2023·2023-05-31

    TruBoost Drink Citrine Spark Recalled for Prohibited Dietary Ingredients

    TruVision Health LLC is recalling TruBoost Drink - Citrine Spark because it contains DMHA and/or hordenine, which the FDA has determined are not acceptable dietary ingredients. Consumers should not consume the product.

    Product
    TruBoost Drink - Citrine Spark
    Category
    Food
    Distribution
    50 states
  • HighFDA (Drugs)·D-0673-2023·2023-05-31

    Cardioplegia Solution Recall Due to Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling cardioplegia solution due to lack of assurance of sterility. An FDA inspection raised concerns about whether the 329 bags were properly sterilized.

    Product
    Cardioplegia Solution, Modified St Thomas Formula, HIGH POTASSIUM, 122 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0209-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0689-2023·2023-05-31

    Neonatal TPN Starter Bag Recalled Due to Sterility Concerns

    Central Admixture Pharmacy Services recalled 92 bags of Neonatal TPN Starter Bag nationwide after FDA inspection questioned product sterility assurance.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0418-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0752-2023·2023-05-31

    Potassium Acetate Injection Recalled for Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling Potassium Acetate Injection after an FDA inspection raised concerns about sterility assurance. The recall affects 3,326 bags nationwide.

    Product
    Potassium Acetate Injection, 2 mEq/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8078-1, code 7128580781.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0936-2023·2023-05-31

    Simple Truth Plant Based Ranch Dressing Mislabeled as Caesar Dressing

    Litehouse Inc. is recalling Simple Truth Plant Based Ranch Dressing 12 oz bottles (UPC 01110609779) because bottles labeled as ranch dressing contain Caesar dressing instead. Affected product has lot code 1713802052623 and was distributed in Indiana.

    Product
    Simple Truth Plant Based Ranch Dressing 12floz bottle UPC 01110609779. 6 retail bottle per wholesale case.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0654-2023·2023-05-31

    FDA Recalls Cardioplegia Solution Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to lack of sterility assurance. An FDA inspection questioned sterility of 254 bags distributed nationwide.

    Product
    Cardioplegia Solution, Reperfusate 4:1 low potassium/low tromethamine, 15 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0009-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0917-2023·2023-05-31

    Country Cookie Pumpkin Bars Recalled for Undeclared Milk Allergen

    Country Cookie Pumpkin Bars are being recalled because the product label fails to declare milk as an ingredient, posing a risk to consumers with milk allergies. Products with 'Baked On' dates through April 17, 2023, distributed in Missouri and Kansas are affected.

    Product
    Country Cookie Pumpkin Bar, plastic clamshell
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0758-2023·2023-05-31

    Glimepiride Tablets recalled due to manufacturing practice deviations

    Amerisource Health Services is recalling 105,361 bottles of Glimepiride Tablets nationwide following FDA discovery of manufacturing practice deviations. No illnesses have been reported.

    Product
    Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 68001-178-03 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. For BluePoint Laboratories
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0714-2023·2023-05-31

    FDA Recalls Norepinephrine Injection Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling 2,041 bags of norepinephrine injection nationwide due to FDA concerns about product sterility. Healthcare providers should immediately stop using affected lots.

    Product
    norepinephrine 4 mg added to dextrose 5% 250 mL*, 16 mcg/mL, 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6056-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0656-2023·2023-05-31

    FDA Recalls Microplegia Solution for Sterility Assurance Concerns

    Central Admixture Pharmacy Services recalls Microplegia Solution due to sterility assurance concerns identified during an FDA inspection. Affected product should not be used.

    Product
    Microplegia Solution, MSA/MSG 0.92 Molar with CP2D, packaged in 120 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0012-2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0690-2023·2023-05-31

    Neonatal TPN Starter Bags Recalled Over Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 418 bags of neonatal TPN starter bags nationwide due to loss of sterility assurance following FDA inspection. The prescription product contains amino acids, dextrose, calcium, and heparin.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0419-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0918-2023·2023-05-31

    Brooklyn Delhi Ghost Pepper Hot Sauce Recalled Due to Pressurization Risk

    Brooklyn Delhi Ghost Pepper Hot Sauce may become pressurized during fermentation, posing a risk of eye, face, and hand injuries when opening the bottle. Consumers should stop using the product and contact the manufacturer.

    Product
    Brooklyn Delhi Ghost Pepper Hot Sauce, 5 oz., glass bottle
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0650-2023·2023-05-31

    Cardioplegia Solution Nationwide Recall Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 255 bags of Cardioplegia Solution after FDA inspection questioned its sterility assurance. The product was distributed nationwide.

    Product
    Cardioplegia Solution, Reperfusate No Potassium, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0005-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0728-2023·2023-05-31

    Potassium Phosphate Drug Product Recalled for Sterility Assurance Defect

    Central Admixture Pharmacy Services recalled 2,146 bags of potassium phosphate with sodium chloride solution nationwide because FDA inspection raised concerns about whether the sterile products met required sterility standards.

    Product
    potassium phosphate 30 mmole added to 0.9% sodium chloride 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7016-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1628-2023·2023-05-31

    VITROS Chemistry HbA1c Reagent Kit recalled due to inaccurate test results

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry HbA1c Reagent Kits due to potential for false-positive and false-negative results, which may lead to misdiagnosis.

    Product
    VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. Product Code: 6842905
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0748-2023·2023-05-31

    Vasopressin Injectable Recalled Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling vasopressin 40 units injectable because FDA inspection raised concerns about sterility assurance.

    Product
    vasopressin 40 units added to 0.9% sodium chloride 100 mL*, 0.4 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9001-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0723-2023·2023-05-31

    Drug Recall: Vancomycin Injectable Lacks Sterility Assurance

    Central Admixture Pharmacy Services recalls 7,632 bags of vancomycin injectable (NDC 71285-6078-1) nationwide due to FDA-identified sterility assurance deficiency.

    Product
    vancomycin added to 0.9% sodium chloride, 2 g/500 mL* (4 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6078-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0738-2023·2023-05-31

    FDA Recalls Diphenhydramine Injectable for Sterility Assurance Deficiency

    Central Admixture Pharmacy Services is recalling 3,999 units of diphenhydramine injectable due to sterility assurance concerns identified during an FDA inspection. No illnesses have been reported.

    Product
    diphenhydrAMINE 50 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7090-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0896-2023·2023-05-31

    Turkey and Havarti Sandwich Recalled for Undeclared Sesame Allergen

    GH Foods LLC recalls Turkey and Havarti Sandwiches for containing sesame seeds not declared on the label. Sesame is a common allergen, and individuals with sesame allergies should not consume this product.

    Product
    Turkey and Havarti Sandwich NET WT. 8.55oz (242g) Perishable, Keep Refrigerated Contains Milk, Soy, Wheat. May contain egg. Distributed By: Renaissance Food Group, LLC 1730 Eastridge Ave. Riverside, CA 92507 www.rfgfoods.com UPC 26766 15584
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0948-2023·2023-05-31

    Truvy Boost Dietary Supplement Kit Recalled for Unapproved Ingredients

    TruVision Health LLC is recalling Truvy Boost 30-Day Experience Kit (Lot 13993) because it contains DMHA and/or hordenine, which FDA has determined are not acceptable dietary ingredients.

    Product
    Truvy Boost 30-Day Experience Kit
    Category
    Drug
    Distribution
    50 states
  • HighFDA (Drugs)·D-0667-2023·2023-05-31

    Cardioplegia Solution Recalled Due to Sterility Concerns

    Central Admixture Pharmacy Services is recalling 476 bags of Cardioplegia Solution nationwide because an FDA inspection raised concerns about the product's sterile assurance.

    Product
    Cardioplegia Solution, Maintenance 4:1 Plasma-Lyte/Tromethamine, low potassium, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0112-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0706-2023·2023-05-31

    Injectable oxyTOCIN and Lactated Ringer's Recalled Over Sterility Concerns

    Central Admixture Pharmacy Services is recalling oxyTOCIN with Lactated Ringer's injection (14,362 bags) nationwide due to FDA inspection findings that questioned sterility assurance.

    Product
    oxyTOCIN 20 units added to Lactated Ringer's 1,000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6038-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1614-2023·2023-05-31

    Cranial Hand Drill recalled due to rust on chuck components

    Integra LifeSciences Corp. is recalling 337 units of the Codman Cranial Hand Drill due to rust contamination on the drill chuck. The rust may cause inflammation, infection, and complications requiring revision surgery.

    Product
    Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage device. Part Number: 82-6607
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0678-2023·2023-05-31

    Cardioplegia Solution Recalled Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services recalls Cardioplegia Solution due to failed sterility assurance after FDA inspection. 363 bags distributed nationwide.

    Product
    Cardioplegia Solution, Induction 8:1 non-enriched, HIGH POTASSIUM, 70 mEq K, packaged in 300 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0214-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0900-2023·2023-05-31

    Country Cookie Peanut Butter Chocolate Chip Cookies Missing Milk Allergen Declaration

    Country Cookie LLC is recalling Country Cookie Peanut Butter Chocolate Chip cookies sold in Missouri and Kansas retailers because milk is not declared on the label despite being present in the product.

    Product
    Country Cookie Peanut Butter Chocolate Chip cookie, plastic wrapped
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0727-2023·2023-05-31

    FDA Recalls Phenylephrine Injectable Due to Sterility Concerns

    Central Admixture Pharmacy Services is recalling 5,304 bags of phenylephrine injection nationwide after FDA inspection raised concerns about product sterility assurance.

    Product
    PHENYLephrine added to 0.9% sodium chloride, 25 mg/250 mL* (100 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7011-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0648-2023·2023-05-31

    Microplegia injectable recalled for lack of sterility assurance

    Central Admixture Pharmacy Services recalls Microplegia injectable solution due to FDA concerns about sterility assurance. The product was distributed nationwide across the United States.

    Product
    Microplegia (MSA/MSG 0.92 Molar) packaged in 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0001-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0739-2023·2023-05-31

    Heparin sodium chloride injection recalled nationwide due to sterility assurance questions

    Central Admixture Pharmacy Services is recalling 1,300 bags of heparin injection nationwide after an FDA inspection questioned the product's sterility assurance.

    Product
    heparin added to 0.9% sodium chloride, 2,500 units/250 mL* (10 units/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8000-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0726-2023·2023-05-31

    FDA Recalls Heparin-Sodium Chloride Injection Nationwide for Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 3,055 bags of heparin injection nationwide due to sterility assurance concerns identified during FDA inspection. Healthcare providers and patients should discontinue use of affected lots.

    Product
    heparin added to 0.9% sodium chloride, 7,500 units/1,000 mL* (7.5 units/mL), 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7009-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0663-2023·2023-05-31

    Cardioplegia Solution Nationwide Recall Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 308 bags of Cardioplegia Solution nationwide because an FDA inspection raised concerns about the product's sterility assurance.

    Product
    Cardioplegia Solution, Maintenance 8:1 low potassium, 24 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0105-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0655-2023·2023-05-31

    Cardioplegia Solution Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling a cardioplegia solution used in cardiac surgery due to lack of assured sterility following an FDA inspection. The product poses a potential infection risk to surgical patients.

    Product
    Cardioplegia Solution, Warm Induction 4:1 HIGH POTASSIUM/low tromethamine, 40 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0011-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0660-2023·2023-05-31

    FDA Recalls Cardioplegia Solution Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling 544 bags of Cardioplegia Solution distributed nationwide due to lack of sterility assurance identified during FDA inspection. No illnesses have been reported.

    Product
    Cardioplegia Solution, Induction 8:1 High Potassium, 108 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0102-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0688-2023·2023-05-31

    Neonatal TPN Starter Bag Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling Neonatal TPN Starter Bags after FDA inspection questioned whether these injectable products maintain required sterility standards.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10% with CALCIUM and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0416-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0735-2023·2023-05-31

    FDA Recalls Phenylephrine Injectable Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling 1,735 bags of phenylephrine injectable nationwide after FDA inspection raised concerns about product sterility assurance. No illnesses have been reported.

    Product
    phenylephrine 50 mg added to 0.9% sodium chloride 250 mL*, 200 mcg/mL*, 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7039-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0937-2023·2023-05-31

    Great Value Potato Chips Recalled for Undeclared Milk Protein

    Great Value Kettle Cooked Lightly Salted Potato Chips from an Ohio distribution center were packaged with incorrect labeling that fails to declare milk protein, posing a risk to consumers with milk allergies.

    Product
    Great Value Kettle Cooked Lightly Salted Potato Chips packaged in 8oz individual plastic bags - 8 bags per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1623-2023·2023-05-31

    Philips Incisive CT System Recalled for Potential Image Orientation Error

    Philips recalls the Incisive CT whole-body X-Ray imaging system in 22 units due to potential incorrect image orientation that could result in flipped or reversed images, leading to misdiagnosis, incorrect treatment, or unnecessary radiation exposure.

    Product
    Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Drugs)·D-0649-2023·2023-05-31

    Cardioplegia Solution recalled due to lack of sterility assurance

    Central Admixture Pharmacy Services is recalling its Cardioplegia Solution due to lack of assurance of sterility. An FDA inspection determined that the sterility of these products intended for cardiac surgery could not be assured.

    Product
    Cardioplegia Solution, Warm Induction 4:1 High Potassium (40 mEq) packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0002-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0721-2023·2023-05-31

    Vancomycin and Dextrose Injection Sterility Recall by Central Admixture

    Central Admixture Pharmacy Services recalls 10,282 bags of vancomycin in dextrose 5% nationwide after FDA inspection raised sterility assurance concerns for this injectable pharmaceutical product.

    Product
    vancomycin added to dextrose 5%, 1.5 g/250 mL* (6 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6075-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0902-2023·2023-05-31

    Oatmeal Raisin Cookies Recalled for Undeclared Milk Allergen

    Country Cookie LLC is recalling Oatmeal Raisin Cookies because the label does not declare milk allergen. The recall affects cookies distributed to retailers in Missouri and Kansas.

    Product
    Country Cookie Oatmeal Raisin Cookie, plastic wrapped
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0665-2023·2023-05-31

    Cardioplegia Solution Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services, Inc. is recalling 48 bags of Cardioplegia Solution after an FDA inspection found the manufacturer could not assure the product's sterility. The product was distributed nationwide.

    Product
    Cardioplegia Solution, Induction 8:1 High Potassium/low dextrose, 100 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0107-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0753-2023·2023-05-31

    Lidocaine Injectable Solution Recalled for Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling Lidocaine 2% HCl Injectable Solution nationwide due to lack of sterility assurance following an FDA inspection. The recall affects 1,516 bags distributed across the United States.

    Product
    Lidocaine 2% HCl Inj, 500mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8091-1, code 7128580911.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0904-2023·2023-05-31

    Country Cookie Sugar Cookies Recalled for Undeclared Milk Allergen

    Country Cookie LLC is recalling Country Cookie Sugar Cookies because the allergen statement does not declare milk, a common allergen. Affected products were distributed to retailers in Missouri and Kansas.

    Product
    Country Cookie Sugar Cookie, plastic wrapped
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0715-2023·2023-05-31

    Phenylephrine Injectable Solution Recalled for Sterility Assurance Issues

    Central Admixture Pharmacy Services is recalling 6,407 bags of phenylephrine injectable solution nationwide because FDA inspection questioned the sterility assurance of the product.

    Product
    PHENYLephrine added to 0.9% sodium chloride, 10 mg/250 mL* (40 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6058-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0734-2023·2023-05-31

    NORepinephrine Injectable Recalled Nationwide for Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 6,341 bags of NORepinephrine nationwide due to FDA concerns about sterility assurance. An FDA inspection found the manufacturer could not adequately ensure the product's sterility.

    Product
    NORepinephrine added to 0.9% sodium chloride, 16 mg/250 mL* (64 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7036-1.
    Category
    Drug
    Distribution
    Distributed nationwide

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