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CGMP Deviations: Presence of NDMA impurity detected in product.
This recall involves the ALOCANE® Emergency Burn Pads (10 count and 15 count) which come in a white and red box with "MAXIMUM STRENGTH ALOCANE® Emergency Burn Pads" printed on the front. The product is an over the counter Gel Infused Pad with lidocaine (4%) as the active ingredient. The pads are sold in a 10 count box and 15 count box with the lot numbers 4179, 4180, 4235, 4645, 4646 or 4698 printed next to the barcode on the box. The UPC number for the affected product is 8-46241-02448-7 and can be found on the bottom of the box.
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
This recall involves bottles of prescription medications Losartan Potassium and Ezetimibe from Sandoz with certain lot numbers. The recalled bottles have "Sandoz," the name of the medication, dosage, and NDC on the front of the bottle labels and the lot number and expiration date on the side of the bottle labels. The recall includes the following: Recalled Prescription Drugs NDC Numbers Lot Numbers Expiration Date Ezetimibe 10mg Tablets 0781-5690-31 JE4491 Aug-2020 30 count bottle JE4492 Aug-2020 JE4493 Aug-2020 JE4495 Aug-2020 JG0308 Sep-2020 JG0310 Sep-2020 JG0311 Sep-2020 JG0312 Sep-2020 JG5061 Sep-2020 JG5063 Sep-2020 JK8921 Oct-2020 JK8922 Oct-2020 JK8923 Oct-2020 JK8924 Oct-2020 JL5535 Oct-2020 JM2253 Oct-2020 JM2254 Oct-2020 JM2255 Oct-2020 JM2257 Oct-2020 JM2258 Oct-2020 JM2259 Oct-2020 JM5986 Oct-2020 JM5987 Oct-2020 Ezetimibe 10mg Tablets 0781-5690-92 JE4481 Aug-2020 90 count bottle JG0249 Sep-2020 JK8989 Oct-2020 JN0764 Jan-2021 Losartan Potassium 50mg Tablets 0781-5701-31 HV9471 Feb-2020 30 count bottle
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Product contains insufficient Higenamine and the label incorrectly declares Cayenne Pepper (CapsiMax) and Choline Bitartrate.
This recall involves Hush gel, spray and foam soap products containing 4% lidocaine. The gel and spray were sold in 2 and 4-ounce sizes and the foam soap was sold in 1.7-ounce size. The bottles are white or black and have printed in green at the front the Hush logo or the phrase Hush and the type of product. The Drug Facts label is on the back. The lot number and expiration date are stamped on the bottom of the container. All lot numbers included in the recall.
This recall involves TriDerma Pain Relief Cream with 4% Lidocaine in a jar and tube. The 4 ounce jar is white with a lime green and pink printed label and has a white dome cap. The 2.2 ounce tube is white with a lime green and pink printed label. The lot numbers and expiration dates of the affected products can be found on the bottom of the jar and on the front of the crimped end of the tube. "TriDerma Pain Relief Cream" is printed on the jar and tube. Lot Number Expiration Date 21088 04/2021 20189 04/2021 0738F02A 06/2021 0738F04A 06/2021 0738F04B 06/2021 0738F04C 06/2021 0739A22A 01/2022 0739A22B 01/2022 0739A23A 01/2022