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

101–200 of 754

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-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-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 (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-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 (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 (Food)·F-0907-2023·2023-05-31
Country Cookie Cranberry Oatmeal White Chocolate cookies recalled for undeclared milk allergen
Country Cookie LLC recalls Cranberry Oatmeal White Chocolate cookies distributed in Missouri and Kansas because the allergen statement does not declare milk. Consumers with milk allergies should not consume this product.
Product
Country Cookie Cranberry Oatmeal White Chocolate cookie, plastic wrapped
Category
Food
Distribution
2 states
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 (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-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 (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 (Food)·F-0935-2023·2023-05-31
Turkey and Havarti Sandwich Recalled for Undeclared Sesame Allergen
Garden Highway Southwest is recalling turkey and havarti sandwiches due to undeclared sesame allergen. Products distributed to KS, NE, MO, LA, and TX with sell-by dates through April 29, 2023 pose a risk to consumers with sesame allergies.
Product
Turkey and Havarti Sandwich Net Wt 8.55 oz (242g) UPC 826766155842 packaged in plastic clamshell container
Category
Food
Distribution
5 states
HighFDA (Food)·F-0903-2023·2023-05-31
Country Cookie Sprinkled Sugar Cookies Recalled for Undeclared Milk Allergen
Country Cookie Sprinkled Sugar Cookies are being recalled because the label does not declare the presence of milk. Consumers with milk allergies should not consume the affected cookies.
Product
Country Cookie Sprinkled Sugar Cookie, plastic wrapped
Category
Food
Distribution
2 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-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-0927-2023·2023-05-31
Cocktail Sauce Recalled for Undeclared Fish and Soy Allergens
Washington Crab & Seafood Company is recalling 52 cups of 8-ounce Cocktail Sauce distributed in North Carolina and South Carolina due to undeclared fish and soy allergens.
Product
COCKTAIL SAUCE Ingredients: Ketchup horseradish, vinegar Worcestershire sauce garlic salt Net Wt 8 oz WASHINGTON CRAB Carolina seafood
Category
Food
Distribution
2 states
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-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 (Food)·F-0934-2023·2023-05-31
Meijer Sweet & Salty Trail Mix recalled for undeclared wheat and sesame
Meijer Inc is recalling Meijer Sweet & Salty Trail Mix (12oz pouches) due to undeclared wheat and sesame ingredients. Consumers allergic to these allergens should not consume the product.
Product
Meijer Sweet & Salty Trail Mix 12oz. pouch, UPC 7 08820 10371 9
Category
Food
Distribution
7 states
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 (Food)·F-0941-2023·2023-05-31
Dietary supplement recalled for containing banned ingredients DMHA and hordenine
TruVision Health is recalling TruControl 7 Day Trifold dietary supplement (lot WKW72353) because it contains DMHA and hordenine, which the FDA determined are not acceptable dietary supplement ingredients.
Product
TruControl 7 Day Trifold
Category
Food
Distribution
50 states
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 (Food)·F-0906-2023·2023-05-31
Cookies and Cream Cookies Recalled Due to Undeclared Milk Allergen
Country Cookie LLC is recalling Cookies and Cream cookies because the label fails to declare milk as an ingredient. Consumers with milk allergies should not eat these cookies.
Product
Country Cookie Cookies and Cream cookie, plastic wrapped
Category
Food
Distribution
2 states
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 (Food)·F-0942-2023·2023-05-31
reFORM Dietary Supplement Recalled for Containing Unapproved Ingredients
TruVision Health LLC is recalling reFORM dietary supplement because it contains DMHA and/or hordenine, which the FDA has determined are not acceptable dietary ingredients.
Product
reFORM
Category
Food
Distribution
50 states
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 (Food)·F-0949-2023·2023-05-31
TruBoost 7 Day Experience Kit dietary supplement recalled for prohibited ingredients
TruVision Health LLC recalls TruBoost 7 Day Experience Kit due to the presence of DMHA and/or hordenine, which the FDA determined are not acceptable dietary ingredients.
Product
TruBoost 7 Day Experience Kit
Category
Food
Distribution
50 states
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 (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 (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 (Food)·F-0912-2023·2023-05-31
Country Cookie Snickerdoodle Cookies Recalled for Undeclared Milk Allergen
Country Cookie LLC is recalling Snickerdoodle Cookies because the allergen statement fails to declare milk. Consumers with milk allergies are at risk of an allergic reaction.
Product
Country Cookie Snickerdoodle Cookie, plastic wrapped
Category
Food
Distribution
2 states
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 (Food)·F-0910-2023·2023-05-31
Country Cookie No Bake cookies recalled for undeclared milk allergen
Country Cookie LLC is recalling Country Cookie No Bake cookies and Country Cookie Cup of Mini Cookies No Bake sold in MO and KS because the allergen statement fails to declare milk.
Product
Country Cookie No Bake cookie, plastic wrapped; Country Cookie Cup of Mini Cookies No Bake
Category
Food
Distribution
2 states
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 (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 (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-0916-2023·2023-05-31
Country Cookie Carrot Cake Recalled for Undeclared Milk Allergen
Country Cookie LLC recalled Country Cookie Carrot Cake products because the packaging fails to declare milk as an allergen. The recall affects clamshell packages distributed to retailers in Missouri and Kansas.
Product
Country Cookie Carrot Cake, plastic clamshell
Category
Food
Distribution
2 states
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-0747-2023·2023-05-31
Injectable Vasopressin Products Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalled 1,858 bags of injectable vasopressin nationwide due to FDA concerns about sterility assurance. An FDA inspection questioned whether the products meet required sterility standards.
Product
vasopressin 20 units added to 0.9% sodium chloride 100 mL*, 0.2 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9000-1.
Category
Drug
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-0694-2023·2023-05-31
Neonatal TPN Starter Bags recalled due to sterility assurance concerns
Central Admixture Pharmacy Services is recalling 128 bags of Neonatal TPN Starter Bag after FDA inspection raised concerns about sterility assurance. The product is used for intravenous nutritional support in newborns.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 6%/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 71285-0423-1.
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-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 (Drugs)·D-0743-2023·2023-05-31
NORepinephrine Injectable Solution Recalled for Sterility Assurance Failure
Central Admixture Pharmacy Services recalls 2890 bags of NORepinephrine injection due to lack of sterility assurance following FDA inspection. The product, distributed nationwide, has affected lots with expiration dates through July 2023.
Product
NORepinephrine added to dextrose 5%, 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 71285-8095-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0696-2023·2023-05-31
Neonatal TPN Bags Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 259 neonatal TPN bags nationwide due to lack of assurance of sterility following FDA inspection.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% 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 71285-0427-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0671-2023·2023-05-31
Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls Cardioplegia Solution (Maintenance 4:1 in Ringer's) due to lack of sterility assurance confirmed by FDA inspection. The product is used during cardiac surgery and distributed nationwide.
Product
Cardioplegia Solution, Maintenance 4:1 in Ringer's, low potassium, 12 mEq K, packaged in 504.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0205-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0691-2023·2023-05-31
Neonatal Injectable TPN Bags Recalled Over Sterility Assurance Concerns
Central Admixture Pharmacy Services recalled 877 bags of neonatal TPN starter bags nationwide due to lack of sterility assurance following an FDA inspection.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/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 71285-0420-1.
Category
Drug
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-0722-2023·2023-05-31
Vancomycin Injectable Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services recalls 9,037 bags of vancomycin injectable due to FDA concerns about sterility assurance. Products distributed nationwide may not meet required sterility standards.
Product
vancomycin added to 0.9% sodium chloride, 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 71285-6076-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0657-2023·2023-05-31
FDA Recalls Plasma-Lyte A Transplant Solution for Sterility Assurance Concerns
The FDA has recalled Plasma-Lyte A Transplant Solution (165 mL bags) due to lack of assurance of sterility following an FDA inspection. This recall affects nationwide distribution.
Product
Transplant Solution (Plasma-Lyte A), packaged in 165 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0014-2.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0717-2023·2023-05-31
Vancomycin injection recalled due to sterility assurance concerns
Central Admixture Pharmacy Services is recalling vancomycin injections (1 g/250 mL) nationwide due to concerns about sterility assurance identified during FDA inspection. The recall affects 4,390 bags.
Product
vancomycin added to 0.9% sodium chloride, 1 g/250 mL* (4 mg/mL), 25 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6064-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0764-2023·2023-05-31
Nafcillin for Injection Recalled Nationwide for Lack of Sterility Assurance
Sagent Pharmaceuticals has recalled Nafcillin for Injection due to lack of sterility assurance. The recall affects approximately 370,200 bottles distributed nationwide.
Product
Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0672-2023·2023-05-31
Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling its Cardioplegia Solution after an FDA inspection raised concerns about product sterility. The recall affects 333 bags distributed nationwide.
Product
Cardioplegia Solution, Induction 4:1 in Ringer's, HIGH POTASSIUM, 48 mEq K, packaged in 522.8 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0206-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0740-2023·2023-05-31
FDA recalls oxytocin admixture bags for lack of sterility assurance
Central Admixture Pharmacy Services is recalling 2,186 bags of oxytocin intravenous admixture nationwide due to lack of sterility assurance following an FDA inspection.
Product
oxyTOCIN 40 units added to 0.9% sodium chloride 1,000 bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8069-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0746-2023·2023-05-31
Heparin Solution Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 2,992 bags of heparin solution nationwide due to failure of sterility assurance discovered during FDA inspection.
Product
heparin added to 0.9% sodium chloride, 2,500 units/500 mL* (5 units/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8100-1.
Category
Drug
Distribution
Distributed nationwide
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 (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-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
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-0724-2023·2023-05-31
FDA Recalls Injectable Phenylephrine Solution Due to Sterility Assurance Issue
Central Admixture Pharmacy Services is recalling 14,205 bags of injectable phenylephrine solution nationwide following FDA inspection findings regarding sterility assurance. The product is prescription-only with nationwide distribution.
Product
PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6092-1.
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 (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
HighFDA (Drugs)·D-0687-2023·2023-05-31
Neonatal Parenteral Nutrition Starter Bags Recalled for Sterility Concerns
Central Admixture Pharmacy Services is recalling 258 bags of Neonatal TPN Starter Bag due to lack of assurance of sterility following an FDA inspection. The product is distributed nationwide.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 5% with CALCIUM, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0413-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0709-2023·2023-05-31
Injectable oxyTOCIN solution recalled nationwide after sterility assurance questioned
Central Admixture Pharmacy Services is recalling oxyTOCIN 20 units in 0.9% sodium chloride injectable solution nationwide after an FDA inspection raised questions about the products' sterility assurance.
Product
oxyTOCIN 20 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 72185-6043-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0704-2023·2023-05-31
FDA Recalls Oxytocin Injectable Bags Due to Sterility Assurance Failure
FDA recalls 2,989 bags of oxytocin mixed with Lactated Ringer's solution nationwide due to lack of sterility assurance. An FDA inspection raised questions about whether the injectable drug met sterility standards.
Product
oxyTOCIN 10 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 72185-6036-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0653-2023·2023-05-31
FDA Recalls Cardioplegia Solution Over Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling Cardioplegia Solution, Reperfusate 4:1 due to lack of sterility assurance identified during an FDA inspection. The recall affects 338 bags distributed nationwide.
Product
Cardioplegia Solution, Reperfusate 4:1 low potassium, 15 mEq K, packaged in 477.5 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0008-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0705-2023·2023-05-31
Oxytocin and Lactated Ringer's Injection Recalled for Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling 560 bags of oxytocin 15 units in Lactated Ringer's 250 mL after FDA inspection questioned the sterility of these products.
Product
oxyTOCIN 15 units added to Lactated Ringer's 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6037-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0710-2023·2023-05-31
Oxytocin Injectable Solution Recalled for Sterility Assurance Questions
Central Admixture Pharmacy Services is recalling oxytocin injectable solution after FDA inspection questioned sterility. Over 104,000 bags distributed nationwide are affected.
Product
oxyTOCIN 30 units 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 71285-6044-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0677-2023·2023-05-31
Microplegia Solution Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services recalls Microplegia Solution (HIGH POTASSIUM) nationwide due to FDA inspection findings questioning sterility assurance. 79 bags affected.
Product
Microplegia Solution, HIGH POTASSIUM (100 mEq), packaged in 200 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0213-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0898-2023·2023-05-31
Country Cookie Chocolate Chip Cookies Recalled for Undeclared Milk Allergen
Country Cookie is recalling Chocolate Chip Cookies sold in Missouri and Kansas because the packaging does not declare milk as an allergen, despite milk being present in the product.
Product
Country Cookie Chocolate Chip Cookie, plastic wrapped; Mini Cups of Cookies Chocolate Chip Cookie
Category
Food
Distribution
2 states
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 (Drugs)·D-0737-2023·2023-05-31
Diphenhydramine 25 mg intravenous bags recalled for lack of sterility assurance
Central Admixture Pharmacy Services recalls 5,627 bags of diphenhydramine 25 mg intravenous solution nationwide. An FDA inspection called into question the sterility of the products intended to be sterile.
Product
diphenhydrAMINE 25 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 71285-7089-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0675-2023·2023-05-31
FDA Recalls Cardioplegia Solution Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling 226 bags of Cardioplegia Solution due to lack of assurance of sterility following FDA inspection. No illnesses reported.
Product
Cardioplegia Solution, Maintenance 4:1 Plasmalyte, low potassium, low K, packaged in 1047 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0211-1.
Category
Drug
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-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-0659-2023·2023-05-31
Cardioplegia Solution Recalled Due to Sterility Assurance Concerns
Cardioplegia Solution is recalled due to sterility assurance concerns identified during an FDA inspection. The recall affects 350 bags distributed nationwide.
Product
Cardioplegia Solution, Induction 4:1, HIGH POTASSIUM/low tromethamine, 36 mEq K, packaged in 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-0101-1.
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-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-0749-2023·2023-05-31
Vasopressin Injectable Drug Recalled Due to Sterility Assurance Questions
FDA recalls 4259 bags of vasopressin injectable solution nationwide due to lack of assurance of sterility following an FDA inspection. The affected lots are intended for central pharmacy use.
Product
vasopressin 50 units added to 0.9% sodium chloride 50 mL*, 1 unit/mL*, 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9002-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0763-2023·2023-05-31
Nafcillin Injectable Medication Recalled for Sterility Assurance Failure
Sagent Pharmaceuticals is recalling Nafcillin for Injection, USP 2 gram vials nationwide due to lack of assurance of sterility in the manufacturing process. This FDA Class II recall affects multiple lots distributed across the United States.
Product
Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0692-2023·2023-05-31
Neonatal TPN Starter Bags Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 427 bags of Neonatal TPN Starter Bag due to FDA concerns about sterility assurance. An FDA inspection questioned whether the product met required sterility standards.
Product
Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3.5%/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 71285-0421-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0712-2023·2023-05-31
dilTIAZem Injectable Bags Recalled Nationwide for Sterility Concerns
Central Admixture Pharmacy Services is recalling 1,230 bags of dilTIAZem injectable due to lack of sterility assurance following FDA inspection. Affected lots were distributed nationwide.
Product
dilTIAZem added to dextrose 5%, 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 72185-6054-1.
Category
Drug
Distribution
Distributed nationwide
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-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-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 (Drugs)·D-0676-2023·2023-05-31
FDA Recalls Cardioplegia Solution Due to Sterility Assurance Issues
Central Admixture Pharmacy Services is recalling Cardioplegia Solution due to FDA concerns about sterility assurance. The recall affects 52 bags distributed nationwide.
Product
Cardioplegia Solution, Induction 4:1 Plasmalyte, HIGH POTASSIUM, HIGH K, packaged in 542 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0212-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0741-2023·2023-05-31
Tromethamine Injectable Syringes Recalled Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling 225 syringes of tromethamine 0.3 Molar nationwide due to lack of sterility assurance identified during an FDA inspection. No illnesses have been reported.
Product
tromethamine 0.3 Molar, 50 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-8086-2.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0669-2023·2023-05-31
Cardioplegia Solution Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services recalls Cardioplegia Solution (182 bags, nationwide distribution) due to lack of sterility assurance identified during FDA inspection.
Product
Cardioplegia Solution, Modified St Thomas Solution, low potassium, HIGH SODIUM BICARBONATE, 62 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0203-1.
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-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
ModerateFDA (Drugs)·D-0757-2023·2023-05-31
Nationwide Recall of Glimepiride Tablets for Manufacturing Practice Deviations
Amerisource Health Services LLC recalls 63,335 bottles of Glimepiride Tablets nationwide due to manufacturing practice deviations identified during FDA inspection.
Product
Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-177-03; Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0952-2023·2023-05-31
Culinaria Cashew and Macadamia Mix Recalled for Label Mix-Up
Culinaria Branded Roasted & Salted Colossal Cashew & Macadamia Mix (828 cans, Lot 3033A9) is being recalled due to a label mix-up. The product was distributed in Illinois, Indiana, and Missouri.
Product
Culinaria Branded Roasted & Salted Colossal Cashew & Macadamia Mix. Net Wt 9oz (255g) UPC 0 41318-22428 3. Distributed by Schnuck Markets, Inc., St. Louis, MO 63146-6928.
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-1480-2023·2023-05-31
Fluoroscopic Imaging System May Display Incorrect Radiation Dose Measurements
Siemens Luminos dRF Max fluoroscopic imaging systems may occasionally display incorrect radiation dose measurements during certain operating conditions. The manufacturer states the error does not affect diagnosis or workflow.
Product
Luminos dRF Max (VE10, VF10, VF11)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1615-2023·2023-05-31
ViziShot 2 Aspiration Needle recalled for manufacturing angle defect
ViziShot 2 Aspiration Needles are being recalled because the needle angle does not meet specifications and remains unbent, causing resistance during use. No illnesses or injuries have been reported.
Product
ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A
Category
Medical Device
Distribution
0 states
ModerateFDA (Food)·F-0943-2023·2023-05-31
Dietary supplement recalled for containing unapproved ingredients
TruVision Health LLC is recalling truControl W/Dynamine because the product contains DMHA and/or hordenine, which FDA has determined are not acceptable dietary ingredients.
Product
truControl W/Dynamine 60 ct
Category
Food
Distribution
50 states
ModerateFDA (Devices)·Z-1632-2023·2023-05-31
Siemens Atellica CH Toxicology Calibrator Reassignment Due to Positive Bias
Siemens Healthcare Diagnostics is reassigning Atellica CH Toxicology Calibrators due to a positive bias. The affected calibrators were distributed in the US and internationally across multiple countries.
Product
Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use in calibrating the Acet, ETOH and Sal assays using the Atellica¿ CH Analyzer Siemens Material Number (SMN): 11099440
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0944-2023·2023-05-31
Dietary Supplement Recall: TruWeight and Energy Gen 2+ Contains Banned Ingredients
TruVision Health is recalling TruWeight and Energy Gen 2+ because it contains DMHA and hordenine, which FDA has determined are not acceptable dietary ingredients. No illnesses have been reported.
Product
TruWeight and Energy Gen 2+ 60 Count
Category
Food
Distribution
50 states
ModerateFDA (Drugs)·D-0767-2023·2023-05-31
Fentanyl Buccal Tablets Recalled for Missing or Incorrect Package Insert
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets (200mcg) due to missing or incorrect package inserts. Patients should contact their healthcare provider if they have affected product.
Product
Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-635-28
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0940-2023·2023-05-31
Dietary Supplement TruCONTROL Recalled Due to Unapproved Ingredients
TruVision Health's truCONTROL 60 Count dietary supplement is being recalled because it contains DMHA and/or hordenine, which the FDA has determined are not acceptable dietary ingredients.
Product
truCONTROL 60 Count
Category
Food
Distribution
50 states

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