Class II · Moderate risk
Bupropion Hydrochloride Extended-Release Tablets USP
Failed Tablet/Capsule Specifications
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
Acetaminophen Injection 1000 mg/100 mL
Discoloration
Class II · Moderate risk
Tavaborole Topical Solution 5%
Discoloration
Class II · Moderate risk
Icosapent Ethyl Capsules 1 gram
Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.
Class II · Moderate risk
DOBUTamine Injection
Discoloration; discolored solution from cracked vials
Class II · Moderate risk
Acetaminophen Tablets
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Class III · Low risk
Venlafaxine Extended-Release Tablets
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Class I · High risk
Prograf (tacrolimus)
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class I · High risk
Astagraf XL
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Class III · Low risk
Methadone Hydrochloride Tablets
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Class II · Moderate risk
Dapsone Gel 7.5%
Crystallization
Class II · Moderate risk
Dapsone Gel 7.5%
Crystallization
Class II · Moderate risk
Dihydroergotamine Mesylate Injection
Discoloration
Class II · Moderate risk
Compliance Dishwashing Liquid & Antibacterial Soap
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk
Genuine Joe Antibacterial Lotion Soap
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk
ROYALAB Germ Away Antibacterial Hand Soap
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk
Array Liquid Antiseptic Handwash
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk
boardwalk ANTIBACTERIAL HANDSOAP REFILL
cGMP Deviations: Out of specification results for micro in hand soap products.
Class II · Moderate risk
MAXIM Assure Antibacterial
cGMP Deviations: Out of specification results for micro in hand soap products.
Class III · Low risk
IBU (ibuprofen)
Failed Tablet/Capsule Specifications
Class II · Moderate risk
Dapsone Gel 7.5%
Crystallization
Class II · Moderate risk
Lanthanum Carbonate Chewable Tablets
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Class II · Moderate risk
Lanthanum Carbonate Chewable Tablets
Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
Class III · Low risk
Kids' Cough and Chest Congestion
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Class III · Low risk
Adult Cough and Chest Congestion
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
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