Class III · Low risk
Leucovorin Calcium Tablets USP
Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
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
Prednisolone Sodium Phosphate Oral Solution
Discoloration: Out of Specification (OOS) result for APHA Color Test.
Class II · Moderate risk
Soft Whisper by Powerstick Dandruff Shampoo
cGMP Deviations: Soft Whisper Dandruff Shampoo was produced with water that failed USP specifications.
Class III · Low risk
Potassium Acetate Injection
Short Fill
Class II · Moderate risk
Aloprim (allopurinol sodium)
Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and Color of Solution.
Class III · Low risk
Esomeprazole Magnesium Delayed Release Capsules USP
Discoloration: product contains brown pellets
Class II · Moderate risk
Pantoprazole Sodium Delayed-Release Tablets
CGMP Deviations: Presence of dark brown discoloration on edges of tablets
Class II · Moderate risk
Epinephrine Injection USP
CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.
Class III · Low risk
Potassium Chloride Extended-Release Tablets USP
Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.
Class I · High risk
Phenytoin Oral Suspension USP
Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
Class II · Moderate risk
Testosterone Cypionate for Injection
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Class II · Moderate risk
Testosterone Cypionate for Injection
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Class III · Low risk
Tri-Lo-Marzia
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Class II · Moderate risk
Blisovi Fe 1.5/30
Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
Class III · Low risk
Moxifloxacin Ophthalmic Solution USP
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Class II · Moderate risk
Vancomycin Hydrochloride for Injection
Discoloration: Product complaints of discoloration after reconstitution of vials.
Class II · Moderate risk
Fluphenazine Decanoate Injection USP 125mg/5mL
Discoloration; Hazy solution found in one vial instead of a clear solution.
Class III · Low risk
Amiodarone Hydrochloride Injection
Crystallization: Presence of visible particulate matter.
Class III · Low risk
Amiodarone Hydrochloride Injection
Crystallization: Presence of visible particulate matter.
Class III · Low risk
Amiodarone Hydrochloride Injection
Crystallization: Presence of visible particulate matter.
Class II · Moderate risk
Leucovorin Calcium Injection
Crystallization: Presence of particulate matter identified as API crystallization
Class II · Moderate risk
Pantoprazole Sodium Delayed Release Tablets
CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
Class III · Low risk
Eptifibatide Injection
Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Class II · Moderate risk
Ascorbic Acid 500 MG/ML
Crystallization
Class II · Moderate risk
Ascorbic Acid 400 MG/ML
Crystallization
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