Class III · Low risk Terminated
UN1002 Air
Reason CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
FDA Drug Recalls
1,523 recalls · Class III, newest first
Class III · Low risk Terminated
UN1002 Air
Reason CGMP Deviations: Confirmed customer compliant of odor when turning on a cylinder of medical air.
Class III · Low risk Terminated
ClomiPHENE CITRATE Tablets
Reason Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
Class III · Low risk Terminated
Bravelle 75 IU
Reason Subpotent Drug
Class III · Low risk Terminated
ImproVue Ophthalmic Lubricant Drops
Reason Falied pH specification
Class III · Low risk Terminated
Lamivudine Oral Solution
Reason 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 Terminated
Hydrocortisone and Acetic Acid Otic Solution
Reason 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 Terminated
Rifampin for Injection USP
Reason Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Ampicillin Capsules
Reason Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.
Class III · Low risk Terminated
Methocarbamol Tablets
Reason Presence of Foreign Substance: Presence of hair.
Class III · Low risk Terminated
Topicort
Reason 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 Terminated
Dexmethylphenidate HCl Extended-Release
Reason 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 Terminated
Hydralazine Hydrochloride Injection
Reason 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 Terminated
Meijer Loratadine Orally Disintegrating Tablets
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk Terminated
Wal-itin Loratadine Orally Disintegrating Tablets
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk Terminated
Sunmark loratadine Orally Disintegrating Tablets
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk Terminated
Up&Up loratadine orally disintegrating tablets
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk Terminated
TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.