May 2023 recalls

754 recalls were announced in May 2023.

What the numbers show

Critical: 15
Severe: 133
High: 527
Moderate: 72
Low: 7

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

Which agencies issued them

101–200 of 754

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 (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 (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 (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-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-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-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 (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 (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 (Devices)·Z-1629-2023·2023-05-31
Arjo Portable Scale Adaptor Model 700.05725 Recalled for Potential Strap Detachment
Arjohuntleigh Magog, Inc. is recalling certain Arjo Portable Scale Adaptors due to straps with potential to detach. Three units were distributed in Ohio and New York.
Product
Arjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be used in combination with compatible patient lifting equipment
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1619-2023·2023-05-31
Medical Device Spine Pack Light Handles May Separate During Surgical Use
Windstone Medical Packaging recalls Aligned Medical Solutions Spine Pack kits due to light handle covers that may separate during surgery. This could delay procedures and compromise the sterile field, potentially injuring patients.
Product
Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO
Category
Medical Device
Distribution
1 state
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-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 (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-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-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 (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-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-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 (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-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-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 (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-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 (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 (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-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 (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-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-0762-2023·2023-05-31
Nafcillin for Injection recalled nationwide for lack of sterility assurance
Sagent Pharmaceuticals is recalling Nafcillin for Injection, USP due to lack of assurance of sterility. Approximately 2.2 million vials distributed nationwide are affected.
Product
Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10
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-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-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 (Food)·F-0939-2023·2023-05-31
Julie's Real Dark Chocolate Granola Bars recalled for possible metal contamination
Julie's Real Foods is recalling Julie's Real JR Bar Dark Chocolate Grain-Free Granola Bars due to possible metal fragments. The affected 6-pack boxes were distributed nationwide.
Product
Julie's Real JR Bar Dark Chocolate Grain-Free Granola Bar, Net Wt 1.4 oz (40g), UPC 857628006705, 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 (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-0771-2023·2023-05-31
Compounded Tirzepatide Injections Recalled Nationwide Due to Sub-Potency
Revive Rx is recalling 45 vials of compounded tirzepatide 10 mg/0.5 mL injections nationwide due to sub-potency. Patients should contact their healthcare provider about their medication.
Product
Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive Rx, 3831 Golf Dr A, Houston, TX 77018, NDC: 99000-9278-64.
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 (Drugs)·D-0761-2023·2023-05-31
Bupropion Hydrochloride Extended-Release Tablets Recalled for Failed Dissolution Specifications
Sun Pharmaceutical is recalling nationwide certain lots of Bupropion Hydrochloride Extended-Release Tablets 150 mg because tablets from these lots failed to meet dissolution specifications during stability testing, potentially affecting drug effectiveness.
Product
BUPROPION HYDROCHLORIDE — BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
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 (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-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-0680-2023·2023-05-31
Cardioplegia Solution Recalled Nationwide Due to Unverified Sterility
Central Admixture Pharmacy Services is recalling 79 bags of Cardioplegia Solution nationwide because an FDA inspection found that the sterility of the product could not be assured.
Product
Cardioplegia Solution, LEESBURG CARDIOPLEGIA, packaged in 1030.2 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0218-1.
Category
Drug
Distribution
Distributed nationwide
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 (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 (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-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 (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-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-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-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 (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-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 (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 (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-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 (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 (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 (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-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
HighNHTSA·23E042000·2023-05-31
IMT Hydraulic Loaders Recalled for Cracking Stabilizer Beam Welds
Iowa Mold Tooling is recalling IMT Hydraulic Loaders because stabilizer beam welds may crack and break, posing a tip-over risk.
Product
EQUIPMENT recall
Category
Vehicle
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 (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
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-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-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 (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-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-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-0718-2023·2023-05-31
Vancomycin Injectable Solution Recalled Due to Sterility Assurance Concerns Nationwide
Central Admixture Pharmacy Services is recalling 3,075 bags of vancomycin injectable solution nationwide due to lack of assurance of sterility following an FDA inspection.
Product
vancomycin added to 0.9% sodium chloride, 750 mg/250 mL* (3 mg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6071-1.
Category
Drug
Distribution
Distributed nationwide
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-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-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-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-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 (Drugs)·D-0733-2023·2023-05-31
Phenylephrine Injectable Solution Recalled Over Sterility Assurance Failure
Central Admixture Pharmacy Services recalls 13,953 bags of phenylephrine injectable solution nationwide due to FDA concerns about sterility assurance identified during inspection.
Product
PHENYLephrine added to 0.9% sodium chloride, 20 mg/250 mL* (80 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7025-1.
Category
Drug
Distribution
Distributed nationwide
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-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 (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 (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-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-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-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-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 (Drugs)·D-0729-2023·2023-05-31
Epinephrine Injection Recalled Due to Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling epinephrine injection (4 mg/250 mL) following FDA inspection findings that the product's sterility cannot be assured.
Product
EPINEPHrine added to dextrose 5%, 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 71285-7018-1.
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 (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 (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-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 (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
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 (Drugs)·D-0768-2023·2023-05-31
Fentanyl Buccal Tablets 400mcg missing or incorrect package insert
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 400mcg due to incorrect or missing package inserts in affected cartons distributed nationwide. No illnesses have been reported.
Product
Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-636-28
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0759-2023·2023-05-31
Glimepiride 4 Milligram Tablets Nationwide Recalled for Manufacturing Practice Deviations
Amerisource Health Services LLC is recalling 129,849 bottles of Glimepiride Tablets, USP 4 mg nationwide due to manufacturing practice deviations identified during an FDA inspection. No illnesses have been reported.
Product
Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories
Category
Drug
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-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
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 (Devices)·Z-1616-2023·2023-05-31
Olympus Fine Needle Aspiration Needles Recalled for Angle Non-Conformance
Olympus is recalling 1,297 boxes of fine needle aspiration needles due to a manufacturing defect where the needle angle does not meet specifications, resulting in slight resistance during needle advancement and retraction.
Product
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 Models: NA-U401SX-4022, NA-U401SX-4022-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-1479-2023·2023-05-31
Fluoroscopic imaging system may display incorrect radiation dose readings
Siemens Luminos Agile Max fluoroscopic imaging systems may occasionally display incorrect radiation dose information under certain unlikely circumstances. The manufacturer states there is no impact on clinical workflow or diagnosis. The error only occurs in systems with a second overhead X-ray tube.
Product
Luminos Agile Max (VE10, VF10, VF11)
Category
Medical Device
Distribution
Distributed nationwide

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