Class II · Moderate risk
PredniSONE Tablets USP
Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
Other failed specifications
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present.
394 FDA drug recalls with this cause, newest first.
Every drug has a specification sheet: pH, viscosity, moisture, tablet hardness, colour, fill volume, disintegration time. A lot that misses any of them is out of specification, even when the active ingredient is present in the right amount. These recalls include discoloured tablets, crystals forming in a solution, capsules that split, and short-filled containers. They are rarely Class I, but they signal a process that has drifted.
Class II · Moderate risk
DOBUTamine Injection
Discoloration: Firm received complaints of product discoloration and particulates.
Class II · Moderate risk
Diazepam Injection USP 10mg/2mL
Crystallization: Product contains particulate identified to be crystallized active ingredient.
Class III · Low risk
Urea (50% Urea in a Cream Base)
Crystallization; complaints received by the manufacturer of crystals forming in product
Class III · Low risk
CEFTRIAXONE for Injection USP
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
Class III · Low risk
Remeven Cream
Crystallization; Complaints that cream appears to have crystallized
Class III · Low risk
Divalproex Sodium Delayed-release Tablets USP
Failed Tablet/Capsule Specifications
Class III · Low risk
Benzphetamine Hydrochloride Tablets
Discoloration: presence of scuffing marks on tablets.
Class II · Moderate risk
Zoloft (sertraline HCl)
Failed Tablet/Capsule Specifications: thick tablets exceeding specifications were found.
Class II · Moderate risk
Brevibloc DOUBLE STRENGTH Premixed Injection
Discoloration: presence of atypical yellow discoloration of the solution .
Class III · Low risk
Lisinopril Tablets USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk
Lisinopril Tablets USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk
Lisinopril & Hydrochlorothiazide Tables
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk
Magnesium Sulfate Inj.
Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
Class III · Low risk
Ceftriaxone Sodium
CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
Class III · Low risk
Ceftriaxone for Injection USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk
Ceftriaxone for Injection USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk
Ceftriaxone for Injection USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk
Ceftriaxone for Injection USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk
Amlodipine Besylate Tablets USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class III · Low risk
Amlodipine Besylate Tablets USP
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Class II · Moderate risk
Lyrica (pregabalin)
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
Class II · Moderate risk
Lyrica (pregabalin)
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
Class III · Low risk
Paricalcitol Capsules
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Class III · Low risk
Paricalcitol Capsules
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
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