Class III · Low risk Terminated
E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent
Reason Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
MethylPREDNISolone TABLETS
Reason Subpotent; 6 month stability time point
Class III · Low risk Terminated
Warfarin Sodium Tablets
Reason Failed Content Uniformity Specifications.
Class III · Low risk Terminated
Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg
Reason Failed Impurity/Degradation Specification; high out of specification for CAD II degradant
Class III · Low risk Terminated
CHIROTHIN Dietary Supplement
Reason Marketed without an Approved NDA/ANDA; Product contains unapproved hHCG.
Class III · Low risk Terminated
Nicotine Polacrilex Lozenge
Reason Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.
Class III · Low risk Terminated
Simvastatin Tablets
Reason Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.
Class III · Low risk Terminated
Rifampin for Injection USP
Reason Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
Class III · Low risk Terminated
Depo-Medrol
Reason Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The registered specification for pH is 3.0 - 7.0
Class III · Low risk Terminated
Cataflam
Reason Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.
Class III · Low risk Terminated
OXYCODONE HYDROCHLORIDE C II Oral Solution USP
Reason Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
Class III · Low risk Terminated
Clonidine HCl Injection
Reason Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride".
Class III · Low risk Terminated
buPROPion HCl Extended-Release Tablets
Reason Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
Class III · Low risk Terminated
Orphenadrine Citrate Extended Release Tablets
Reason Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Class III · Low risk Terminated
Viracept
Reason Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016. The correct expiry date is 09/2016.
Class III · Low risk Terminated
Triamcinolone Acetonide Lotion USP
Reason Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Class III · Low risk Terminated
Triamcinolone Acetonide Lotion USP
Reason Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Class III · Low risk Terminated
Diltiazem HCl Extended-release Capsules
Reason Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Class III · Low risk Terminated
E-Z-Hd
Reason Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
Class III · Low risk Terminated
Lortuss Ex
Reason Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Class III · Low risk Terminated
Poly-Tussin Ac Liquid
Reason Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Class III · Low risk Terminated
Tolterodine Tartrate Tablets
Reason Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.
Class III · Low risk Terminated
Famotidine for Oral Suspension
Reason Failed Impurity/Degradation Specification; 12-month stability time point
Class III · Low risk Terminated
Diltiazem HCl Extended Release Capsules
Reason Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Class III · Low risk Terminated
Cardura XL
Reason Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.