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All product recalls associated with KVK Tech, Inc..
Total Recalls
15
Past Year
2
Class I (Serious)
2
Most Recent
May 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
cGMP deviations
cGMP deviations
Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP 5 mg in bottles.
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Presence of Foreign Substance; Fiber particles.
Labeling: Wrong bar code
Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
Discoloration: presence of scuffing marks on tablets.
Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.