Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS…
Reason Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
2,661 recalls, newest first
Reason Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Reason Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Reason Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent…
Reason Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
Reason Presence of particulate matter: a white thread-like structure in the cartridge
Reason Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Reason Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the…
Reason Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Reason Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Reason Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Reason Lack of assurance of Sterility: potential product contamination
Reason Lack of assurance of Sterility: potential product contamination
Reason CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Reason Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Reason Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Reason Chemical contamination; presence of lead and lithium above specification
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Labeling: Missing Label
Reason Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914…
Reason Subpotent drug
Reason Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Reason CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Reason CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Reason CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry