Class III · Low risk Terminated
Tadalafil SR 7 mg Capsules packed in 8
Reason Labeling Not Elsewhere Classified: Misbranding.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Progesterone SR 200 mg Capsules
Reason Labeling Not Elsewhere Classified: Misbranding.
Class III · Low risk Terminated
Progesterone SR 100 mg Capsules
Reason Labeling Not Elsewhere Classified: Misbranding.
Class III · Low risk Terminated
Altavera Levonorgestrel and Ethinyl Estradiol Tablets
Reason Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
Class III · Low risk Terminated
treatNOW ABILIFY
Reason Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.
Class III · Low risk Terminated
treatNOW ABILIFY
Reason Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.
Class III · Low risk Terminated
Fenofibrate Tablets
Reason Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.
Class III · Low risk Terminated
Zoledronic Acid Injection
Reason Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Class III · Low risk Terminated
Zoledronic Acid Injection
Reason Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Class III · Low risk Terminated
Calcium Gluconate 2.5% a) 250 mL 25 mg/mL NDC 69699-0908-25
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
Bupropion Hydrochloride ER Tablets
Reason Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.
Class III · Low risk Terminated
Pramipexole dihydrochloride extended release tablets
Reason Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
Class III · Low risk Terminated
Argatroban Injection
Reason Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Class III · Low risk Terminated
MethylPREDNISolone Tablets
Reason Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
Class III · Low risk Terminated
Levonorgestrel and Ethinyl Estradiol Tablets
Reason Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
Class III · Low risk Terminated
Morphine Sulfate Extended-Release Tablets
Reason Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing.
Class III · Low risk Terminated
Oxycodone and Acetaminophen Tablets
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices contain the correct lot number of FG10517.
Class III · Low risk Terminated
Tyvaso Inhalation System Patient a) Starter Kit with TYVASO
Reason Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Class III · Low risk Terminated
Diltiazem HCl Extended-release Capsules
Reason Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
Class III · Low risk Terminated
Valsartan Tablets USP
Reason Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk Terminated
Valsartan Tablets USP
Reason Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk Terminated
Valsartan Tablets USP
Reason Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk Terminated
Valsartan Tablets USP
Reason Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk Terminated
Contrave
Reason Defective Container: Customer complaints of punctures in the bottle.
Class III · Low risk Terminated
Azelastine HCl Ophthalmic Solution 0.05%
Reason Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide