Undeclared Wheat flour. Product contains wheat flour but product was sold without the Ingredients Statement.
All Recalls
95,075 total recalls in our database
Happy Moose Juice Tropical Roots packaged in a plastic 12 fl. oz. bottle. Ingredients: Mandarin Orange, Organic Carrot Juice, Organic Pineapple Juice, Lemon Juice, and Organic Turmeric Juice. UPC 860012096503
Youngstown Grape Distributors
Incomplete pasteurization
Farmers Juice Focus Greens packaged in a 12 fl. oz. bottle; Ingredients: Cucumber, Celery, Fennel, Romaine Lettuce, Lemon, Mint, Green Cabbage, Ginger, Turmeric, Basil, & Matcha. UPC: 00860006798048
Youngstown Grape Distributors
Incomplete pasteurization
Salmonella.
Farmers Juice Watermelon Hydration packaged in a 12 fl. oz. bottle; Ingredients: Watermelon, Lime, Mint
Youngstown Grape Distributors
Incomplete pasteurization
Dry Dates, 50 lb. bag
BlueStar Direct
No label- Undeclared sulfur dioxide
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58
Fresenius Kabi Compounding
cGMP violations
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58
Fresenius Kabi Compounding
cGMP violations
EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58
Fresenius Kabi Compounding
cGMP violations
Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59
Fresenius Kabi Compounding
cGMP violations
AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,
C & A Naturistics
Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58
Fresenius Kabi Compounding
cGMP violations
CGMP Deviations
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58
Fresenius Kabi Compounding
cGMP violations
Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56
Fresenius Kabi Compounding
cGMP violations
Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58
Fresenius Kabi Compounding
cGMP violations
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58
Fresenius Kabi Compounding
CGMP violations
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58
Fresenius Kabi Compounding
cGMP violations
Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK, REF DYNJ24362C; b) MAJOR GYNE LAPAROSCOPY SHSC, REF DYNJ46774B; c) GYN ANCILARY PACK, REF DYNJ84509; d) GYN LITHOTOMY MINOR, REF DYNJ907707
MEDLINE INDUSTRIES, LP - Northfield
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.