131 FDA recalls mention Menthol. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Menthol.
Reason CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good…
Reason CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good…
Reason CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good…
Reason Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the net weight is 2.75 oz. rather than the correct net…
Reason Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
Reason Superpotent Drug: high out of specification assay results for the menthol ingredient.
Reason Superpotent Drug: high out of specification assay results for the camphor ingredient.
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Reason CGMP Deviations: products may be contaminated with bacteria.
Reason CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
Reason CGMP Deviations: the product was produced with substandard GMP manufacturing processes.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle
Reason CGMP Deviations
Reason Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.
Reason Marketed without an approved NDA/ANDA
Reason Labeling: Incorrect Instructions; The word not is missing from the following sentences "do bandage tightly or cover with any type of wrap except…
Reason Presence of Foreign Tablets/Capsules: Presence of comingled Sugar Free Honey Lemon cough drops.
Reason Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of the active ingredient menthol.
Reason Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due…
Reason Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due…
Reason Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due…
Reason Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due…
Reason Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due…
Reason Labeling:Label Mixup; BENZOCAINE/MENTHOL Lozenge, 15 mg/2.6 mg may be potentially mislabeled as CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS, Tablet, 120…
Reason Labeling:Label Mixup; BENZOCAINE/MENTHOL Lozenge, 15 mg/3.6 mg may be potentially mislabeled as LUBIPROSTONE, Capsule, 24 mcg, NDC 64764024060…
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