Class I - Dangerous
Labeling: Label mix-up - the label on the product may not match the formula in the bottle.
🏥
Over-the-Counter
💊 Drugs • 328 recalls
Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottle, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875518028
Valeant Pharmaceuticals North America
Class I - Dangerous
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875521011
Valeant Pharmaceuticals North America
Class I - Dangerous
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875519155
Valeant Pharmaceuticals North America
Class I - Dangerous
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Thayers Natural Remedies, Saline Nasal Spray, Allergy & Sinus Relief, Slippery Elm, 1.5 FL OZ (44 mL) bottle, Distributed By: Product Quest Manufacturing, LLC, 330 Carswell Ave., Daytona Beach, FL 32117, UPC 7 27510 00660 4.
Product Quest Manufacturing
Class I - Dangerous
CGMP Deviations: products manufactured under conditions that could impact its product quality.
CVS Health, Sterile Saline Nasal Mist (sodium chloride) Allergy & Sinus Relief, 3.0%, 4.25 OZ (126 g) can, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 41854 3.
Product Quest Manufacturing
Class I - Dangerous
CGMP Deviations: products manufactured under conditions that could impact its product quality.
Thayers Natural Remedies, Saline Nasal Mist, Allergy & Sinus Relief, Slippery Elm, 3 FL OZ (89 mL) can, Distributed By: Product Quest Manufacturing, LLC, 330 Carswell Ave., Daytona Beach, FL 32117, UPC 7 27510 00659 8.
Product Quest Manufacturing
Class I - Dangerous
CGMP Deviations: products manufactured under conditions that could impact its product quality.
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
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