FDA Drug Recalls

1,523 recalls · Class III, newest first

Class III · Low risk Terminated May 24, 2017

Mefenamic Acid Capsules

Reason Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules

Shionogi Inc. NDC 66993-070-30 D-0219-2018

Class III · Low risk Terminated May 18, 2017

Fludeoxyglucose F 18 Injection

Reason Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent

Lantheus MI Radipharmaceuticals Inc. NDC 11994-015-01 D-0942-2017

Class III · Low risk Terminated May 17, 2017

Nystatin Oral Suspension

Reason Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.

VistaPharm, Inc. NDC 66689-008-02 D-0869-2017

Class III · Low risk Terminated May 9, 2017

Montelukast Sodium Oral Granules

Reason Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities

Mylan Pharmaceuticals Inc. NDC 0378-6040-93 D-0920-2017

Class III · Low risk Terminated May 9, 2017

Benzonatate capsules

Reason Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.

Strides Pharma INC NDC 64380-713-06 D-0858-2017

Class III · Low risk Terminated May 8, 2017

Hydrocortisone Lotion

Reason Superpotent Drug: above specification for the assay.

Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals NDC 0603-7785-52 D-0859-2017

Class III · Low risk Terminated May 5, 2017

Amlodipine Besylate Tablet

Reason PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.

Ascend Laboratories LLC NDC 67877-199-10 D-1134-2017

Class III · Low risk Terminated May 2, 2017

Famotidine for Oral Suspension USP

Reason CGMP Deviations

Lupin Pharmaceuticals Inc. NDC 68180-150-01 D-1127-2017

Class III · Low risk Terminated Apr 27, 2017

Minivelle

Reason Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.

Noven Pharmaceuticals, Inc. D-0923-2017

Class III · Low risk Terminated Apr 27, 2017

Acyclovir Tablets

Reason Presence of Foreign Substance: human hair melded into tablet.

Hetero USA Inc NDC 31722-778-01 D-0897-2017

Class III · Low risk Terminated Apr 26, 2017

Amoxicillin and Clavulanate Potassium Tablets

Reason Subpotent Drug; Clavulanic Acid

Sandoz Inc NDC 0781-1831-20 D-0868-2017

Class III · Low risk Terminated Apr 20, 2017

IC-Green

Reason Product is being recalled due to low pH value.

Akorn, Inc. NDC 17478-701-02 D-0697-2017

Class III · Low risk Terminated Apr 18, 2017

Children's Cetirizine Hydrochloride Chewable Tablets

Reason Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness.

Sun Pharmaceutical Industries, Inc. NDC 47335-343-83 D-0857-2017

Class III · Low risk Terminated Apr 17, 2017

Zinc Oxide Paste 25%

Reason Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.

Fagron, Inc NDC 51522-0694-5 D-0695-2017

Class III · Low risk Terminated Apr 17, 2017

Allergy Relief Diphenhydramine HCl 25 mg

Reason Subpotent: This product is being recalled due to low out of specification assay results at the 9 month time point.

P & L Development, LLC NDC 36800-483-24 D-0694-2017

Class III · Low risk Terminated Apr 7, 2017

Desoximetasone Ointment USP

Reason Superpotent Drug

Teligent, Inc. NDC 52565-030-15 D-0787-2017

Class III · Low risk Terminated Apr 4, 2017

Doxercalciferol Capsules 0.5mcg

Reason Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print.

West-Ward Columbus, Inc. NDC 0054-0338-19 D-0651-2017

Class III · Low risk Terminated Mar 28, 2017