Class I - Dangerous
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
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Over-the-Counter
💊 Drugs • 320 recalls
Class I - Dangerous
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Class I - Dangerous
Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia
Acne Treatment Pads (2% salicylic acid), packaged in a 50-count jar, OTC, Distributed by: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320, NDC 71537-001-02
Huijing (Shanghai) Bio-tech Co.
Class I - Dangerous
Subpotent drug: The product active ingredient level not matching the exact levels indicated on the packaging label.
Class I - Dangerous
Labeling: Not Elsewhere Classified - A private label distributor noted unfiled NDC numbers on EQ ClearLax Polyethylene Glycol 3350 NF Powder Solution of various sizes.
Class I - Dangerous
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class I - Dangerous
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class I - Dangerous
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class I - Dangerous
cGMP Deviations
Class I - Dangerous
cGMP Deviations
Class I - Dangerous
Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans
Class I - Dangerous
GMP Deviations: inadequate manufacturing control processes
Class I - Dangerous
GMP Deviations: inadequate manufacturing control processes
Class I - Dangerous
GMP Deviations: inadequate manufacturing control processes
Class I - Dangerous
GMP Deviations: inadequate manufacturing control processes
Class I - Dangerous
GMP Deviations: inadequate manufacturing control processes
Class I - Dangerous
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class I - Dangerous
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Class I - Dangerous
Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.
Class I - Dangerous
Microbial Contamination of Non Sterile Products; out of specification Total Plate Count