The Recall Desk

Archive

May 2023 recalls

754 recalls were announced in May 2023.

What the numbers show

Critical
15
Severe
132
High
528
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 r
    Category
    Medical Device
    Distribution
    16 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-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
  • 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
  • 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-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
  • 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-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
  • 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-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-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-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-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
  • 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 (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-0684-2023·2023-05-31

    Neonatal TPN Starter Bag Recalled for Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling 71 bags of Neonatal TPN Starter Bag nationwide following an FDA inspection that questioned the product's sterility. The affected lots expire in April and May 2023.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0406-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0700-2023·2023-05-31

    Neonatal Parenteral Nutrition Bags Recalled Due to Sterility Concerns

    Central Admixture Pharmacy Services recalls 175 bags of neonatal TPN solution nationwide due to FDA inspection findings that questioned the sterility assurance of the product.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4.5%/Dextrose 10% with HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0432-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0899-2023·2023-05-31

    Country Cookie Oatmeal Chocolate Chip cookies recalled for undeclared milk allergen

    Country Cookie LLC is recalling Country Cookie Oatmeal Chocolate Chip cookies because the labels do not declare milk as an allergen. The recall affects products with 'Baked On' dates through April 17, 2023, distributed in Missouri and Kansas.

    Product
    Country Cookie Oatmeal Chocolate Chip, plastic wrapped
    Category
    Food
    Distribution
    2 states
  • 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 (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-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 (Devices)·Z-1622-2023·2023-05-31

    Philips CT Scanner May Display Images With Incorrect Orientation

    Philips Incisive CT X-ray systems may display medical images in incorrect orientation, potentially leading to misdiagnosis, incorrect treatment, and unnecessary radiation exposure if rescans are needed.

    Product
    Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 728144
    Category
    Medical Device
    Distribution
    4 states
  • 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-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-0662-2023·2023-05-31

    Cardioplegia Solution Recalled Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling Cardioplegia Solution nationwide due to lack of assurance of sterility after an FDA inspection questioned the product's sterility.

    Product
    Cardioplegia Solution, Maintenance 4:1 low potassium/low tromethamine, 36 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0104-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0913-2023·2023-05-31

    Country Cookie Sugar Frosted Cookie recalled for undeclared milk allergen

    Country Cookie LLC is recalling Country Cookie Sugar Frosted Cookies because the allergen statement on the package does not declare milk. Products with 'Baked On' dates through April 17, 2023, distributed to Missouri and Kansas retailers are affected.

    Product
    Country Cookie Sugar Frosted Cookie, plastic wrapped
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0765-2023·2023-05-31

    Pain Reliever Caplets Recalled Due to Out-of-Specification Impurity

    Aurobindo Pharma is recalling 87,360 bottles of Pain Reliever Acetaminophen caplets (500 mg) distributed nationwide through Walgreens due to failed impurity specifications discovered through customer complaints about discoloration.

    Product
    PAIN RELIEVER — PAIN RELIEVER (ACETAMINOPHEN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0926-2023·2023-05-31

    Blue Crab Dip Recalled for Undeclared Milk Allergen

    Washington Crab & Seafood Company is recalling Blue Crab Dip due to undeclared milk content. Consumers with milk allergies who consume this product may experience allergic reactions.

    Product
    BLUE CRAB DIP 8 oz Ingredients: Blue Crabmeat, cream cheese, vidalia onion, salt, paprika, and spice WASHINGTON CRAB Carolina Seafood
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0911-2023·2023-05-31

    Country Cookie Peanut Butter Cookies Recalled for Undeclared Milk Allergen

    Country Cookie LLC is recalling peanut butter cookies sold in Missouri and Kansas because the allergen label does not declare milk, posing a risk to consumers with milk allergies.

    Product
    Country Cookie Peanut Butter Cookie, plastic wrapped
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0736-2023·2023-05-31

    FDA Recalls Vancomycin Injectable Solution Due to Sterility Concerns

    Central Admixture Pharmacy Services is recalling 8,252 bags of vancomycin injection nationwide after FDA inspection raised concerns about product sterility. Affected lots expire May through June 2023.

    Product
    vancomycin added to 0.9% sodium chloride, 1.75 g/500 mL* (3.5 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7060-1.
    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 (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 (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, Sugar,
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-1624-2023·2023-05-31

    Incisive CT Power X-Ray System may display flipped or reversed images

    The Incisive CT Power X-Ray System (Model 728148) may display computed tomography images with incorrect orientation—flipped or reversed—potentially leading to misdiagnosis, incorrect treatment, or additional radiation exposure from rescanning.

    Product
    Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Drugs)·D-0732-2023·2023-05-31

    FDA Recalls Heparin Injectable Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 5,207 bags of heparin injectable nationwide due to an FDA-identified sterility assurance failure. The company cannot guarantee the sterility of affected lot numbers.

    Product
    heparin added to 0.9% sodium chloride, 5,000 units/500 mL* (10 units/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7023-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0652-2023·2023-05-31

    FDA Recalls Cardioplegia Solution Due to Sterility Assurance Defect

    Central Admixture Pharmacy Services, Inc. is recalling 140 bags of Cardioplegia Solution due to lack of assurance of sterility following an FDA inspection. The product was distributed nationwide.

    Product
    Cardioplegia Solution, Reperfusate 4:1 low potassium, 7.5 mEq K, packaged in 238.75 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0007-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0730-2023·2023-05-31

    Prescription Injectable Epinephrine and Dextrose Solution Recalled for Sterility Assurance Failure

    Central Admixture Pharmacy Services has recalled nationwide 2,542 bags of prescription-only injectable epinephrine and dextrose solution due to lack of sterility assurance following an FDA inspection.

    Product
    EPINEPHrine added to dextrose 5%, 8 mg/250 mL* (32 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7019-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0682-2023·2023-05-31

    Neonatal TPN Starter Bag Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services recalled 80 Neonatal TPN Starter Bags nationwide due to FDA concerns about sterility assurance after an inspection.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10%, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0400-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0745-2023·2023-05-31

    Drug Recall: NORepinephrine Injectable Solution Due to Sterility Concerns

    Central Admixture Pharmacy Services is recalling NORepinephrine injectable solution nationwide after an FDA inspection questioned the product's sterility assurance. The recall affects 4,994 bags.

    Product
    NORepinephrine added to 0.9% sodium chloride, 4 mg/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 71285-8097-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0668-2023·2023-05-31

    Cardioplegia Solution Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling its Cardioplegia Solution, del Nido Formula, nationwide after an FDA inspection questioned the product's sterility.

    Product
    Cardioplegia Solution, del Nido Formula, packaged in 1,052.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0202-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (Food)·F-0915-2023·2023-05-31

    Country Cookie Banana Cake Recalled for Missing Milk Allergen Declaration

    Country Cookie Banana Cake products are being recalled because their allergen statement does not declare milk. Consumers with milk allergies should not consume these products.

    Product
    Country Cookie Banana Cake, plastic clamshell
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0742-2023·2023-05-31

    FDA recalls epinephrine injection for lack of sterility assurance

    Central Admixture Pharmacy Services recalled 8171 bags of epinephrine injection nationwide due to FDA concerns about sterility. The recalled prescription-only product was distributed across multiple lot numbers with expiration dates in 2023.

    Product
    EPINEPHrine added to 0.9% sodium chloride, 4 mg/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 71285-8093-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0744-2023·2023-05-31

    FDA Recalls NORepinephrine Injection Due to Sterility Concerns

    Central Admixture Pharmacy Services recalled 6,414 bags of NORepinephrine injection nationwide after an FDA inspection questioned the sterility of the product. Healthcare facilities should stop using and quarantine affected lots.

    Product
    NORepinephrine added to 0.9% sodium chloride, 8 mg/250 mL* (32 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8096-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1625-2023·2023-05-31

    Incisive CT Plus imaging system recalled for potential incorrect image orientation

    Philips is recalling 5 Incisive CT Plus CT X-ray systems due to potential defects that may display images with flipped or reversed orientation, risking misdiagnosis, incorrect treatment, and unnecessary radiation exposure from repeat scans.

    Product
    Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Drugs)·D-0699-2023·2023-05-31

    Neonatal TPN Starter Bags Recalled for Lack of Sterility Assurance

    Central Admixture Pharmacy Services is recalling 60 Neonatal TPN Starter Bags distributed nationwide due to sterility assurance concerns identified during an FDA inspection.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/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 71285-0430-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0905-2023·2023-05-31

    Country Cookie Chocolate Chocolate Chip Cookies Recalled for Undeclared Milk

    Country Cookie LLC. is recalling Country Cookie Chocolate Chocolate Chip cookies because the allergen statement does not declare milk. The recall affects cookies distributed in Missouri and Kansas.

    Product
    Country Cookie Chocolate Chocolate Chip cookie, plastic wrapped
    Category
    Food
    Distribution
    2 states
  • 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-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 (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-0760-2023·2023-05-31

    Foaming Hand Sanitizer Recalled for Elevated Acetaldehyde and Acetal Levels

    Alpha Aromatics is recalling foaming hand sanitizer due to elevated levels of acetaldehyde and acetal above FDA specifications. The product was distributed to one account in North Carolina.

    Product
    FOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3.78 Liters bottle, 290 Alpha Drive RIDC industrial Park, Pittsburgh, PA 15238,
    Category
    Drug
    Distribution
    1 state
  • 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 (Food)·F-0897-2023·2023-05-31

    Backpacker's Pantry Blueberry Peach Crisp recalled for undeclared almond allergen

    American Outdoor Products is recalling Backpacker's Pantry Blueberry Peach Crisp pouches because the packaging lacks almond allergen disclosure, though almonds are present in the product.

    Product
    Backpacker s Pantry Blueberry Peach Crisp, 4.6-ounce, packaged in a pouch, UPC-048143026143
    Category
    Food
    Distribution
    49 states
  • 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 (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 (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 (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 (Drugs)·D-0701-2023·2023-05-31

    FDA Recalls Epinephrine Injection Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 3,338 bags of epinephrine injectable solution nationwide. The FDA raised concerns about sterility assurance during an inspection.

    Product
    EPINEPHrine added to dextrose 5%, 2 mg/250 mL* (8 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6030-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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
  • 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 (Drugs)·D-0750-2023·2023-05-31

    FDA Recalls Compounded Injectable Solution Due to Sterility Failure

    Central Admixture Pharmacy Services recalled 653 bags of compounded injectable solution nationwide following an FDA inspection that questioned the product's sterility. The solution is intended for sterile injection use.

    Product
    MSA 7.84% MSG 8.56% (0.92M) Comp. Sol. 1000 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8029-1, code 7128580291.
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (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 (Devices)·Z-1631-2023·2023-05-31

    Medical Device Calibrator Recall for Salicylate Assay Due to Measurement Bias

    Siemens Healthcare is recalling ADVIA Chemistry ToxAmmonia Calibrators due to positive bias in salicylate assay measurements. Affected calibrators were distributed across the US and internationally.

    Product
    ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salicylate (SAL) assays on the ADVIA¿ Chemistry systems Siemens Material Number (SMN): 10309217
    Category
    Medical Device
    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 (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-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-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-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-0658-2023·2023-05-31

    FDA Recalls Cardioplegia Solution Due to Sterility Assurance Issues

    Central Admixture Pharmacy Services is recalling 267 bags of Cardioplegia Solution after FDA inspection raised questions about sterility assurance. The prescription product was distributed nationwide.

    Product
    Cardioplegia Solution, Induction 4:1, High Potassium, 60 mEq K, packaged in 830 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0100-1.
    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-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-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-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-0683-2023·2023-05-31

    Neonatal TPN Starter Bag Recalled for Sterility Assurance Issues

    Central Admixture Pharmacy Services recalls 558 bags of Neonatal TPN Starter Bag nationwide due to lack of sterility assurance identified during an FDA inspection.

    Product
    Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/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 71285-0405-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0945-2023·2023-05-31

    TruWeight and Energy Gen 2+ Supplement Recalled for Unapproved Ingredients

    TruVision Health LLC is recalling TruWeight and Energy Gen 2+ Trifold dietary supplement for containing DMHA and/or hordenine, unapproved ingredients. Consumers with this product should discontinue use.

    Product
    TruWeight and Energy Gen 2+ Trifold
    Category
    Food
    Distribution
    50 states
  • 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-0713-2023·2023-05-31

    Injectable Diltiazem Recalled Over Sterility Assurance Concerns from FDA Inspection

    Central Admixture Pharmacy Services is recalling 3,040 bags of prescription diltiazem injection after FDA inspection raised concerns about product sterility. The medication was distributed nationwide.

    Product
    dilTIAZem added to 0.9% sodium chloride, 125 mg/125 mL* (1 mg/mL), 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6055-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0751-2023·2023-05-31

    Injection Solution Recalled Due to Sterility Assurance Concerns

    Nationwide recall of Sodium Phosphates Injection due to lack of sterility assurance after FDA inspection. Patients receiving this medication should consult their healthcare provider.

    Product
    Sodium Phosphates Injection 4 mEq/3 mMol/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8077-1, code 7128580771.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1621-2023·2023-05-31

    Aligned Medical Solutions Hand Pack covers may detach during surgical use

    Windstone Medical Packaging is recalling Aligned Medical Solutions Hand Pack kits because light handle covers may detach during surgical procedures, potentially compromising the sterile field.

    Product
    Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0661-2023·2023-05-31

    FDA Recalls Cardioplegia Solution for Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling cardioplegia solution due to sterility assurance concerns identified in an FDA inspection. The recall affects 269 bags distributed nationwide.

    Product
    Cardioplegia Solution, Maintenance 4:1 low potassium, 20 mEq K, packaged in 810 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0103-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0651-2023·2023-05-31

    Cardioplegia Solution Recalled Due to Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling Cardioplegia Solution (Reperfusate No Potassium) due to lack of assurance of sterility identified during FDA inspection.

    Product
    Cardioplegia Solution, Reperfusate No Potassium, packaged in 477.5 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0006-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0703-2023·2023-05-31

    OxyTOCIN Injectable Product Recalled for Sterility Assurance Concerns

    Central Admixture Pharmacy Services is recalling 2624 bags of oxyTOCIN due to FDA concerns about product sterility. No illnesses have been reported.

    Product
    oxyTOCIN 30 units added to dextrose 5%/Lactated Ringer's 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6032-1.
    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 (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-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-0720-2023·2023-05-31

    Injectable Vancomycin Admixture Recalled Due to Sterility Assurance Failure

    Central Admixture Pharmacy Services is recalling 27,780 bags of vancomycin injectable solution nationwide after an FDA inspection raised concerns about the product's sterility assurance.

    Product
    vancomycin added to 0.9% sodium chloride, 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 71285-6074-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1620-2023·2023-05-31

    Aligned Medical Solutions hand pack light covers may separate during use

    Windstone Medical Packaging recalls the Aligned Medical Solutions Minor Hand Pack because light handle covers may detach during procedures. This could delay surgery and compromise the sterile field, risking patient injury.

    Product
    Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO
    Category
    Medical Device
    Distribution
    1 state

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