Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
Other Drugs
π Drugs β’ 3,200 recalls
Discoloration
Discoloration
KABOOM action strips, Sexual Performance Strips, packaged in 6.4oz box 12 strips per box, Nutrology USA LLC
Blue Square Market
Marketed Without An Approved NDA/ANDA: presence of undeclared Sulfoaildenafil.
Subpotent Drug: Salicylic acid is subpotent.
Subpotent Drug: Salicylic acid is subpotent.
Subpotent Drug: Salicylic acid is subpotent.
Subpotent Drug: Salicylic acid is subpotent.
Subpotent Drug: Salicylic acid is subpotent.
Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.
Presence of Particulate Matter: Due to customer complaints of small black particles, identified as part of the ointment tube cap, generated by the action of unscrewing the cap from the aluminum tube and potentially introducing the particle into the product.
Chemical Contamination: Naphthalene compound identified in the product after complaints of a petroleum odor.
Falied pH specification
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0547-02
GlaxoSmithkline Consmer Healthcare
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
SENSODYNE EXTRA FRESH COMPLETE PROTECTION, 3.4 oz.(96.4 g) tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0572-02
GlaxoSmithkline Consmer Healthcare
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
SENSODYNE COMPLETE PROTECTION, 3.4 oz. (96.4 g)tubes, Manufactured by Oratech, South Jordan UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0573-02
GlaxoSmithkline Consmer Healthcare
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 g) tubes, (NDC 0135-0559-01), bioteneΒΏ PBF Paste, b) 4.5 oz.(127.6 g) tubes, (NDC 0135-0490-02), Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108
GlaxoSmithkline Consmer Healthcare
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tubes, Manufactured by Oratech, South Jordan, UTAH, 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108 NDC 0135-0558-01
GlaxoSmithkline Consmer Healthcare
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.