Every FDA drug recall initiated in 2017, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,141 recalls, newest first.
Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut the patch" rather than the correct instructions of "Do not cut the patch". The pouch containing the patch is labeled correctly.
Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.
Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of correctly as Buffered Lidocaine 0.9%
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
CGMP Deviations
CGMP Deviations
CGMP Deviations
CGMP Deviations
Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. The hair came in contact with the reconstituted drug product.
Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling.
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets
Defective Container: Leakage of unit dose cups that may occur at the seal.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.