Class II · Moderate risk
Dapsone Gel 7.5%
Crystallization
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 III · Low risk
AcetaZOLAMIDE Tablets
Discoloration
Class II · Moderate risk
Extra Strength Acetaminophen 500 MG Tablets
Discoloration: Brownish tablets
Class III · Low risk
Valacyclovir Tablets USP
Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.
Class II · Moderate risk
Clorazepate Dipotassium Tablets
Discoloration: Dotted and yellow spots on tablets
Class II · Moderate risk
Clorazepate Dipotassium Tablets
Discoloration: Dotted and yellow spots on tablets
Class III · Low risk
Xelpros (latanoprost ophthalmic emulsion)
Failed Release Testing: Out of specification for particulate matter test.
Class II · Moderate risk
Aloe Gator
Out of Specification for active ingredient
Class II · Moderate risk
Natural Pain Relieving Cream
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Pain Wizard
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Natural Pain Relieving Cream
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Natural Pain Relieving Cream
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Pain Wizard
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Pain Wizard
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Aloe Gator
Out of Specification for active ingredient
Class II · Moderate risk
Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech
Out of Specification for active ingredient
Class II · Moderate risk
Natural Pain Relieving Cream
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Pain Wizard
Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Class II · Moderate risk
Clobazam Tablets 10mg
CGMP Deviations: Out of specification for residual solvents.
Class III · Low risk
Nortrel 7/7/7
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Class III · Low risk
Nortrel (norethindrone and ethinyl estradiol tablets USP)
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Class II · Moderate risk
Fluocinolone Acetonide Oil
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
Class III · Low risk
Anoro Ellipta
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
Class II · Moderate risk
ROPivacaine HCl 0.2% PF in Sodium Chloride 1
STAQ Pharma Inc. received consumer complaints related to leaking bags and other potential bag concerns. Upon investigation, they determine the source of the issue was with the bag manufacturer who released bags Lot # 134142-001A which had failed internal QC tests for leaks.
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