Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date
💊
Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Class I - Dangerous
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date
Class I - Dangerous
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date
Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500 g container (NDC: 58597-8023-7), c) 1,000 g container (NDC: 58597-8023-8). For Prescription Compounding RX Only. Packed under cGMP conditions by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
American Pharmaceutical Ingredients
Class I - Dangerous
CGMP Deviations: Lack of quality assurance at the API manufacturer.
Class I - Dangerous
GMP Deviations; FDA inspection found significant manufacturing practices that call into question the safety, identity, strength, quality and purity of unexpired drug products manufactured by the firm.
Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Distributed by: Xttrium Laboratories, Inc., Mount Prospect, IL 60056, NDC 0116-2001-16
Xttrium Laboratories
Class I - Dangerous
CGMP Deviations
Succinylcholine Chloride, 100 mg per 5mL, 20 mg per mL syringe. IV Use Only. JCB Laboratories, 8710 E 34th St., N. Wichita, KS 67226 UPC 7335968405
Fagron Compounding Services LLC
Class I - Dangerous
Lack Of Assurance Of Sterility: voluntary recall initiated by the commercial supplier
Class I - Dangerous
Cross Contamination With Other Product: Imipramine
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product.
Fludeoxyglucose F 18 Injection, 20mCi/mL to 200 mCi/mL at EOS, 30 mL Multiple-Dose Vial, Rx Only, Manufactured by: Lantheus MI Radiopharmaceuticals, Inc., San Juan, PR --- NDC 11994-015-01
Lantheus MI Radipharmaceuticals
Class I - Dangerous
Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date
Class I - Dangerous
Presence of Foreign Substance: possibility of the presence of metal in the product.
Class I - Dangerous
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Progesterone Injection in Olive Oil With Benzyl Alcohol 10%, 50mg/mL, 10mL Multi-Dose Vial, Rx only, Apothecary by Design, 141 Preble Street, Portland, ME.
Apothecary By Design
Class I - Dangerous
Lack of Processing Controls: The metal container closure adheres to the rubber stopper on some of the units of the batch which can impact the integrity of the container closure.