Class III · Low risk
MethylPREDNISolone Tablets
Subpotent; 6 month stability time point
Class III drug recalls - low risk
Class III means the product is unlikely to cause harm but violates FDA labeling or manufacturing rules. These are the recalls you rarely hear about; pharmacies usually just swap the affected lot.
1,716 recalls, newest first.
Class III · Low risk
candesartan cilexetil
Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.
Class III · Low risk
Locoid (hydrocortisone butyrate 0.1%)
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
Class III · Low risk
Hydrocortisone Butyrate Cream 0.1%
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
Class III · Low risk
Amlodipine Besylate Tablets
Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
Class III · Low risk
Truvada (200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate)
Presence of Foreign Substance: Truvada was found to contain small red silicone rubber particulates.
Class III · Low risk
BENZONATATE Capsules
Presence of Foreign Capsules/Tablets: Benzonatate 100 mg co-mingled with benzonatate 200 mg capsules.
Class III · Low risk
E-Z- GAS II EFFERVESCENT GRANULES Antacid/Antiflatulent
Subpotent Drug: Out of Specification (OOS) result during routine stability testing at 24 months.
Class III · Low risk
MethylPREDNISolone TABLETS
Subpotent; 6 month stability time point
Class III · Low risk
Warfarin Sodium Tablets
Failed Content Uniformity Specifications.
Class III · Low risk
Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg
Failed Impurity/Degradation Specification; high out of specification for CAD II degradant
Class III · Low risk
CHIROTHIN Dietary Supplement
Marketed without an Approved NDA/ANDA; Product contains unapproved hHCG.
Class III · Low risk
Nicotine Polacrilex Lozenge
Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution test and presence of broken lozenges.
Class III · Low risk
Simvastatin Tablets
Failed Impurities/Degradation Specifications: Product failed Impurity content (Butylated Hydroxy Anisole Content) against shelf life specification.
Class III · Low risk
Rifampin for Injection USP
Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
Class III · Low risk
Depo-Medrol
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
Cataflam (diclofenac potassium)
Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.
Class III · Low risk
OXYCODONE HYDROCHLORIDE C II Oral Solution USP
Failed Stability Specifications: Out of specification result for preservative sodium benzoate.
Class III · Low risk
Clonidine HCl Injection
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
buPROPion HCl Extended-Release Tablets
Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed.
Class III · Low risk
Orphenadrine Citrate Extended Release Tablets
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Class III · Low risk
VIRACEPT (nelfinavir mesylate)
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
Triamcinolone Acetonide Lotion USP
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Class III · Low risk
Triamcinolone Acetonide Lotion USP
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Class III · Low risk
Diltiazem HCl Extended-release Capsules
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.