Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
4 recalls · Class II, newest first
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Microbial contamination of sterile products
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution