Class III · Low risk Terminated
24-HOUR Oral Care q4 Kit with Ballard* Technology
Reason Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
24-HOUR Oral Care q2 Kit with Ballard* Technology
Reason Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Class III · Low risk Terminated
Chlorhexidine Gluconate Oral Rinse
Reason Subpotent Drug: Product crystallization with accompanying low out of specification results for chlorhexidine assay.
Class III · Low risk Terminated
Fabior
Reason Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.
Class III · Low risk Terminated
Tramadol Hydrochloride 50 mg tablets
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
Indomethacin Capsules USP
Reason Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One or two capsules 2 or 3 times a day." rather than the correct usual adult dosage of "One capsule 2 or 3 times a day.
Class III · Low risk Terminated
buPROPion HCl Extended-Release Tablets
Reason Failed Dissolution Specifications; during stability testing
Class III · Low risk Terminated
buPROPion HCl Extended-Release Tablets
Reason Failed Dissolution Specifications; during stability testing
Class III · Low risk Terminated
Triamcinolone Acetonide Lotion
Reason Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Class III · Low risk Terminated
Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal
Reason Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period.
Class III · Low risk Terminated
Clocortolone Pivalate Cream
Reason Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.
Class III · Low risk Terminated
Decitabine for Injection
Reason Failed impurities/degradation specifications: Failure to water content and impurity
Class III · Low risk Terminated
Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL…
Reason Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product.
Class III · Low risk Terminated
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Flucanazole Injection
Reason Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
Class III · Low risk Terminated
Methylphenidate Hydrochloride Extended-release Tablets
Reason Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
Class III · Low risk Terminated
Lynparza
Reason Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
Class III · Low risk Terminated
labetalol HCl injection 20 mg/4 mL
Reason Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018
Class III · Low risk Terminated
Atropine Sulfate Ophthalmic 1% Solution
Reason Failed Stability Specification: OOS low viscosity results discovered during retain testing.
Class III · Low risk Terminated
Cystaran
Reason Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Class III · Low risk Terminated
Calcium Acetate Capsules
Reason Presence of Foreign Tablets/Capsules
Class III · Low risk Terminated
BonaDur For Men
Reason CGMP Deviations: not manufactured according to current good manufacturing practices.
Class III · Low risk Terminated
Fluoxetine Tablets USP
Reason Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.
Class III · Low risk Terminated
Azelastine HCl Nasal Solution
Reason Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station
Class III · Low risk Terminated
Klonopin
Reason Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.