Class III · Low risk Terminated
Levetiracetam Injection
Reason Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Methylphenidate Hydrochloride Oral Solution 5mg per 5mL
Reason Presence of Foreign Substance; Fiber particles.
Class III · Low risk Terminated
Motion Sickness Strips
Reason Subpotent Drug
Class III · Low risk Terminated
Wal-Dram 2
Reason Subpotent Drug
Class III · Low risk Terminated
Motion Sickness
Reason Subpotent Drug
Class III · Low risk Terminated
Zentrip
Reason Subpotent Drug
Class III · Low risk Terminated
Sankaijo BOTANICAL LAXATIVE
Reason Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
Class III · Low risk Terminated
Testosterone Cypionate Injection
Reason Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml single-dose vials, found to contain shelf cartons labelled as Testosterone Cypionate Injection USP, 200mg/mL, 10 ml multi-dose vials which contain Testosterone Cypionate Injection USP, 200mg/mL,1mL single-does vials
Class III · Low risk Terminated
Benazepril HCl Tablets
Reason Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle
Class III · Low risk Ongoing
Ranitidine Tablets USP
Reason CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
Class III · Low risk Terminated
Sodium Chloride Injection USP 0.9%
Reason Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.
Class III · Low risk Terminated
Zarontin
Reason Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Class III · Low risk Terminated
ethosuximide capsules
Reason Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Class III · Low risk Terminated
Gatifloxacin Ophthalmic Solution 0.5%
Reason Failed Impurities/Degradation Specifications:OOS for unknown impurity.
Class III · Low risk Terminated
Matzim LA
Reason GMP Deviation: lot not intended for commercial distribution.
Class III · Low risk Terminated
Lamivudine Tablets
Reason Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths section of the insert that incorrectly lists the tablet description coding for the tablets.
Class III · Low risk Terminated
minolira
Reason Failed Dissolution Specifications:
Class III · Low risk Terminated
Pramipexole Dihydrochloride Tablets 0.125 mg
Reason Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
Class III · Low risk Terminated
Clotrimazole and Betamethasone Dipropionate Cream USP
Reason Temperature Abuse: Complaints received of liquidy texture.
Class III · Low risk Terminated
Eptifibatide Injection
Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Class III · Low risk Terminated
Eptifibatide Injection
Reason Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Class III · Low risk Terminated
Eptifibatide Injection
Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Class III · Low risk Terminated
Simvastatin Tablets
Reason Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Class III · Low risk Terminated
Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count
Reason Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
Class III · Low risk Terminated
Nystatin and Triamcinolone Acetonide Cream USP100
Reason Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.