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Browse drug and medication recalls including prescription drugs, OTC medications, and supplements. Stay informed about pharmaceutical safety alerts.
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Presence of Particulate Matter: Piece of metal found in a vial
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Identification of an unknown impurity at the 12-month stability point. Further investigation has identified the impurity as Timolol Phenol S-Oxide.
Defective Container: Product has incomplete induction seals.
Defective Container: Tube split from side seam
The recall involves Mohnark Pharmaceuticals Lidocaine 4% Topical Anesthetic Cream. The product was sold in a white tube with a flip-top closure. Mohnark Pharmaceuticals is printed under the blue and green logo on the right side of the product tube. The lot code is located at the bottom of the product tube. The affected lot codes are 01202201, 210201, 210301, 210503, 210505, 210601, 211002 and 210401. The UPC 860002324906 is located on bottom side panel of the packaging.
Failed Tablet/Capsule Specification : Capsule breakage
Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
CGMP Deviations: product held outside appropriate storage temperature conditions.
CGMP Deviations: product held outside appropriate storage temperature conditions.