Class III · Low risk
FUROSEMIDE Tablets USP
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
FDA Drug Recalls
1,525 recalls · Class III, newest first
Class III · Low risk
FUROSEMIDE Tablets USP
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Class III · Low risk
UN1002 Air
CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
Class III · Low risk
UN1002 Air
CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
Class III · Low risk
ClomiPHENE CITRATE Tablets
Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
Class III · Low risk
Bravelle 75 IU
Subpotent Drug
Class III · Low risk
ImproVue Ophthalmic Lubricant Drops
Falied pH specification
Class III · Low risk
Lamivudine Oral Solution
Labeling: Incorrect or Missing Lot and/or Exp. Date - Firm received a customer complaint that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17).
Class III · Low risk
Hydrocortisone and Acetic Acid Otic Solution
Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.
Class III · Low risk
Rifampin for Injection USP
Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium Tablets
Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk
Ampicillin Capsules
Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.
Class III · Low risk
Methocarbamol Tablets
Presence of Foreign Substance: Presence of hair.
Class III · Low risk
Topicort (desoximetasone)
Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.
Class III · Low risk
Dexmethylphenidate HCl Extended-Release
Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.
Class III · Low risk
Hydralazine Hydrochloride Injection
Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
Class III · Low risk
Meijer Loratadine Orally Disintegrating Tablets
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk
Wal-itin Loratadine Orally Disintegrating Tablets
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk
Sunmark loratadine Orally Disintegrating Tablets
Superpotent Drug: Out Of Specification (OOS) result for Assay.