CGMP Deviations:
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Other Drugs
💊 Drugs • 3,313 recalls
ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Dist. by: Endometriosis Assoc. Inc. (International), Mfg. by Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-712-01.
Atlantic Management Resources
Class I - Dangerous
cGMP Deviations
Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in 0.22 Fl. oz. (6.6 mL) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.
Atlantic Management Resources
Class I - Dangerous
cGMP Deviations
Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-711-01.
Atlantic Management Resources
Class I - Dangerous
cGMP Deviations
Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01.
Atlantic Management Resources
Class I - Dangerous
cGMP Deviations
CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol.
Class I - Dangerous
Failed Stability Specifications
Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Class I - Dangerous
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53220 1
Justified Laboratories
Class I - Dangerous
Marketed Without An Approved NDA/ANDA; Unapproved new drug
Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53221 8
Justified Laboratories
Class I - Dangerous
Marketed Without An Approved NDA/ANDA; Unapproved new drug
Antica Farmacista Hand Sanitizer Ocean Citron (ethyl alcohol, denatured 65%) packaged in 473 mL/16 fl. oz. bottles, Dist. By Antica Farmacista Seattle, WA 98122 UPC 8 47005 00450 9
Salon Technologies International
Class I - Dangerous
Chemical Contamination: product found to contain benzene
Sanitizing Hand Spray 80% (alcohol 80% v/v) Packaged in 2 FL OZ (60 mL) bottles, Salon Technologies International 8810 Commodity Circle STE 22-23, Orlando, FL 32819, UPC 6 96952 12904 5
Salon Technologies International
Class I - Dangerous
GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Antibacterial Foaming Wash with Hydria Moisturizing Formula, Cucumber-Melon Scent, 1250 mL (42 fl oz.), Manufactured for: Triple S, 800-323-2251, Made in USA, NDC 11429-1010-8
Woodbine Products Co
Class I - Dangerous
Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label.
TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Carolina Infusion
Class I - Dangerous
Lack of Assurance of Sterility
Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Carolina Infusion
Class I - Dangerous
Lack of Assurance of Sterility
Banana Boat hair & scalp defense, Clear Sunscreen Spray SPF 30, Avobenzone 2.0%, Homosalate 6.0%, Octocrylene 6.0%, packaged in Net Wt 6 oz. aluminum spray can, Distributed by: Edgewell Personal Care Brands, LLC, Shelton, CT 06484, UPC 0 79656 04041 8
Edgewell Personal Care Brands
Class I - Dangerous
Chemical contamination: presence of benzene
Class I - Dangerous
Microbial contamination of non-sterile products.