Class III · Low risk
Xolegel (ketoconazole)
Failed Viscosity specification: Slightly higher OOS results obtained for viscosity
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
Acetaminophen 500 mg tablet
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Class III · Low risk
Acetaminophen 325 mg tablets
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
Class II · Moderate risk
Class III · Low risk
Aspirin and Extended-Release Dipyridamole Capsules
Failed Tablet/Capsule Specification : Capsule breakage
Class II · Moderate risk
Eszopiclone Tablets
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Class II · Moderate risk
Clonazepam Orally Disintegrating Tablets
Failed Tablet/Capsule Specification; oversized tablet found in a bottle
Class III · Low risk
Lidocaine Hydrochloride Oral Topical Solution
Failed viscosity specification - product was below specificcation
Class II · Moderate risk
Methylphenidate Hydrochloride Chewable Tablets
Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.
Class II · Moderate risk
Buprenorphine HCl
Crystallization; identified as Buprenorphine free base
Class II · Moderate risk
VANComycin 1g added to 250mL of 0.9% Sodium Chloride
Crystallization: Product appears to be turbid.
Class III · Low risk
Topiramate Tablets
Discoloration
Class II · Moderate risk
Pregabalin Capsules
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
Class II · Moderate risk
Ezetimibe and Simvastatin Tablets
Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
Class III · Low risk
AllerClear D-24 hr
Failed Moisture Limits
Class III · Low risk
Loratadine-D Extended-Release Tablets
Failed Moisture Limits
Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk
Dr. Reddy's Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Class II · Moderate risk
Aconitum Napellus 12X Fear* 87% Alcohol HPUS: packaged in 30 mL containers
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Aconitum nap Fear* 20% Alcohol HPUS: 6X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Aconitum Napellus Fear* Sucrose/Lactose Pills HPUS: 8X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Aconitum nap Fear* Sucrose/Lactose Pills HPUS: 4X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Aconitum Napellus Fear* 20% Alcohol HPUS: 5X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
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