Class II · Moderate risk
Ascorbic Acid 500 MG/ML
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 II · Moderate risk
Revonto (dantrolene sodium for injection)
Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
Class II · Moderate risk
Pantoprazole Sodium Delayed-Release Tablets
Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
Class III · Low risk
Biotin 10 mg/mL Injection
Failed pH Specification: product does not meet pH label claim.
Class III · Low risk
Mirapex (pramipexole dihydrochloride)
Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
Class III · Low risk
Esomeprazole Magnesium Delayed-Release Capsules USP
Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
Class III · Low risk
Amlodipine and Olmesartan Medoxomil Tablets
Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).
Class III · Low risk
Aprepitant Capsules
Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.
Class III · Low risk
Metoprolol Tartrate Injection
Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.
Class III · Low risk
Prednisolone and Gatifloxacin Ophthalmic Solution
Presence of precipitate
Class III · Low risk
Metoprolol Tartrate Injection
Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
Class II · Moderate risk
Pantoprazole Sodium Delayed-Release Tablets
Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.
Class II · Moderate risk
Clozapine Orally Disintegrating Tablets
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Class I · High risk
Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection
Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
Class II · Moderate risk
Montelukast Sodium Tablets
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Class II · Moderate risk
Indomethacin Capsules
Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
Class II · Moderate risk
Potassium Citrate Extended-Release Tablets
Failed Tablet/Capsule Specifications: Tablet breakage
Class II · Moderate risk
Potassium Citrate Extended-Release Tablets
Failed Tablet/Capsule Specifications: Tablet breakage
Class III · Low risk
Nystatin Oral Suspension
Resuspension problems: Out of specification for appearance and resuspendability.
Class III · Low risk
Ciclopirox Olamine Cream USP
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Class II · Moderate risk
Valsartan Tablets
Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
Class II · Moderate risk
Vertra Elemental Resistance
CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.
Class II · Moderate risk
Clozapine Tablets USP
Failed Tablet/Capsule Specifications; potential presence of broken tablets.
Class III · Low risk
Propafenone Hydrochloride tablets
Failed moisture limits: Out of specification for moisture content.
Class II · Moderate risk
Ketorolac Trom 30 mg/mL Injection
Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been identified as crystalline ketorolac calcium salt.
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