CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Compounded Drugs
💊 Drugs • 1,855 recalls
Labeling: Missing instructions for use insert
Labelling: Missing label.
RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W 0.5 oz. (14.2g), Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011 Made in Canada. UPC 0 11822 53812 1
Taro Pharmaceuticals U.S.A.
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 1 OZ (28.4 g) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. Made in Canada NDC 59779-305-03
Taro Pharmaceuticals U.S.A.
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g), Distributed by CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 UPC 0 50428 53642 1
US Pharmaceuticals
Lack Of CGMP:s Low weight fill tubes were identified in one lot of CVS Healing Ointment.
Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 1 gallon (3785 mL) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-04, UPC 7401037203427.
Genesis Partnership Company SA
CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 240 mL (8 FL OZ.) bottle, Manufactured by Genesis Partnership Company S.A., Guatemala, NDC 74484-002-02, UPC 7401037205773.
Genesis Partnership Company SA
CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
CGMP Deviations
HAND SANITIZER Non-sterile Solution 70% Topical Solution, packaged in 20L (5.28 Gal) plastic containers, Distributed by: Resource Recovery & Trading LLC 4275 Executive Square, Ste. 200 La Jolla, CA 92037, UPC 37710600013
RESOURCE RECOVERY & TRADING
cGMP deviations
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.
Chemical Contamination: Presence of Undeclared Methanol
Incorrect/Undeclared Excipients: Notification received from Health Canada that DA-2I Ethanol is a type not an approved for use in Hand Sanitizer.
Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial
BIOTA Biosciences
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Sterile Curcumin 50mg/mL, 10 mL vial
BIOTA Biosciences
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Sterile Curcumin, 4mg/mL, 10mL vial
BIOTA Biosciences
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial
BIOTA Biosciences
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac
Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial
BIOTA Biosciences
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin