All recalls8,521 total
Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).
High mold, yeast, and total viable count
Product may be contaminated with mold.
undeclared peanuts, almonds and pecans
Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Products may contain undeclared sesame
Products may contain undeclared sesame
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Label declares butter and ghee but does not declare milk.
Label declares butter and ghee but does not declare milk.
Failed Impurities/Degradation Specifications - at 18-month Stability testing
undeclared milk
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Product contains levels of Vitamin D above the maximum level permitted.
CGMP Deviations: sterile water not used for production
CGMP Deviations: sterile water not used for production
Lack of Assurance of Sterility
High levels of Yeast growth and film on top of jarred Kimchi product.
Potential Salmonella contamination.
Clostridium botulinum (uneviscerated fish)
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Guacamole products may be contaminated with Listeria monocytogenes.
Guacamole products may be contaminated with Listeria monocytogenes.
Guacamole products may be contaminated with Listeria monocytogenes.
Guacamole products may be contaminated with Listeria monocytogenes.
Guacamole products may be contaminated with Listeria monocytogenes.
Failed Dissolution Specifications: below specification results
Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Potential L. monocytogenes
Potential Listeria Monocytogenes
Elevated lead levels in cinnamon
Due to elevated levels of lead. Sample collected by Maryland Department Of Health (MDDH) tested positive for high levels of lead in ground cinnamon.
Undeclared Allergen - Sesame seeds
Product may become spoiled due to temperature abuse. The temperature abuse was the result of a malfunctioning refrigeration unit on trailer #184.