October 28, 2020DrugsFDA
Genesis Partnership Company SA recalls Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guatemala, Distributed by Central Med Distributi
Hazard: CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.
October 28, 2020DrugsFDA
Acella Pharmaceuticals, LLC recalls NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceutica
Hazard: Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
October 28, 2020DrugsFDA
Acella Pharmaceuticals, LLC recalls NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceutical
Hazard: Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
October 21, 2020DrugsFDA
ASHTEL STUDIOS, INC. recalls Smart Care HAND SANITIZER, Ethyl Alcohol 62%, packaged in 0.84 FL.OZ (25 mL), labeled as a) Paw Patrol (Item #: 92321-
Hazard: Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleading, resembling food and drink pouches
October 21, 2020DrugsFDA
Leadiant Biosciences, Inc. recalls Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured
Hazard: Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
October 14, 2020DrugsFDA
VistaPharm, Inc. recalls NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL)
Hazard: Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
October 14, 2020DrugsFDA
Direct Rx recalls Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer
October 14, 2020DrugsFDA
Direct Rx recalls Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
October 14, 2020DrugsFDA
Direct Rx recalls Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distr
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
October 14, 2020DrugsFDA
PAI Holdings, LLC. dba Pharmaceutical Associates Inc recalls Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical Associates, Inc. Green
Hazard: Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
October 14, 2020DrugsFDA
Calvin Scott & Company, Inc. recalls Phentermine, 30 mg capsules, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Compan
Hazard: cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
October 14, 2020DrugsFDA
Calvin Scott & Company, Inc. recalls Diethylpropion, 75 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Comp
Hazard: cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
October 14, 2020DrugsFDA
Calvin Scott & Company, Inc. recalls Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Comp
Hazard: cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
October 14, 2020DrugsFDA
PD-Rx Pharmaceuticals, Inc. recalls Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), Liothyronine (T3) 9 mcg, Levothyroxine (T4)
Hazard: CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.
October 7, 2020DrugsFDA
Akorn, Inc. recalls Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsoc
Hazard: CGMP Deviations
October 7, 2020DrugsFDA
pH-D Feminine Health recalls pH-D Feminine Health Boric Acid Vaginal Suppositories, 24 vaginal suppositories per box, 600 mg each, pH-D Feminine Heal
Hazard: Marketed without an Approved NDA/ANDA.
October 7, 2020DrugsFDA
Legacy Pharmaceutical Packaging LLC recalls Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc
Hazard: Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
October 7, 2020DrugsFDA
Arbor Pharmaceuticals Inc. recalls Nymalize (nimodipine) oral solution, 60 mg/20 mL, 12 Unit-Dose Cups and 12 Oral Syringes, 2 inner cartons per outer ship
Hazard: Subpotent Drug
October 7, 2020DrugsFDA
Volu-Sol, Inc. recalls Volu-Sol Handrub Sanitizing Solution (Ethyl Alcohol, 69% v/v and Isopropyl Alcohol, 7.2% v/v) Topical Solution, 473 mL/
Hazard: Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
October 7, 2020DrugsFDA
Direct Rx recalls Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharm
Hazard: CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
October 7, 2020DrugsFDA
4e Brands North America, Llc recalls blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) Packaged as a) 3.4 fl oz / 100 ml bottle, UP
Hazard: Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
October 7, 2020DrugsFDA
4e Brands North America, Llc recalls blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost with tea tree oil (70% ethyl alcohol), 33.8
Hazard: Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
October 7, 2020DrugsFDA
4e Brands North America, Llc recalls blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, U
Hazard: Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
October 7, 2020DrugsFDA
4e Brands North America, Llc recalls Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcohol), 33.8 FL OZ (1 L) bottle, Distributed b
Hazard: CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
October 7, 2020DrugsFDA
4e Brands North America, Llc recalls ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 3
Hazard: CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
October 7, 2020DrugsFDA
4e Brands North America, Llc recalls ASSURED Instant Hand Sanitizer Vitamin E and Aloe, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39
Hazard: CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
October 7, 2020DrugsFDA
4e Brands North America, Llc recalls blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/v), 3.4 fl. oz./100 mL bottle, Distributed
Hazard: CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
October 7, 2020DrugsFDA
4e Brands North America, Llc recalls blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, U
Hazard: CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
October 7, 2020DrugsFDA
4e Brands North America, Llc recalls blumen ADVANCED HAND SANITIZER, 70% ALCOHOL CONTENT, (70% ethyl alcohol), packaged as a) 3.4 fl oz / 100 ml bottle, UPC
Hazard: CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
October 7, 2020DrugsFDA
4e Brands North America, Llc recalls blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost with Tea Tree Oil, (70% ethyl alcohol), Pac
Hazard: CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.