Class II · Moderate risk
Propranolol Hydrochloride Tablets
Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10 mg due to the potential of some tablets not conforming to weight specification.
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
Olanzapine Tablets
Defective Container; This action is being taken as a precautionary measure due to the product being re-packaged in the U.S. using a filler material that (removes or blocks) less moisture than what is approved in the application.
Class II · Moderate risk
Merrem I.V.
Presence of Precipitate; potential for incomplete constitution upon addition of diluent.
Class III · Low risk
Amoxicillin for Oral Suspension
Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.
Class II · Moderate risk
VersaPharm Incorporated
Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink.
Class II · Moderate risk
Nimodipine Capsules 30 mg
Crystallization; crystallized nimodipine
Class I · High risk
Warfarin Sodium Tablets
Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.
Class I · High risk
Piperacillin and Tazobactam for Injection
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Class III · Low risk
Amoxicillin for Oral Suspension
Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.
Class II · Moderate risk
Glimepiride Tablets USP
Failed Tablet/Capsule Specifications: One oversized tablet was found in a sealed 100 count bottle of Glimepiride at the retail level.
Class III · Low risk
Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Class II · Moderate risk
Oxcarbazepine Oral Suspension
Resuspension Problems: Recalled lot did not meet resuspendability requirements.
Class II · Moderate risk
Diclofenac Sodium and Misoprostol Delayed-Release Tablets
Failed Tablet/Capsule Specifications: Broken tablets
Class II · Moderate risk
Diclofenac Sodium and Misoprostol Delayed-Release Tablets
Failed Tablet/Capsule Specifications: Broken tablets
Class I · High risk
Piperacillin and Tazobactam for Injection
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Class III · Low risk
Jolessa (levonorgestrel/ethinyl estradiol)
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
Class III · Low risk
Portia (levonorgestrel and ethinyl estradiol)
Failed Tablet/Capsule Specifications: This recall is being carried out due to an out of specification result for appearance.
Class II · Moderate risk
Venlafaxine Hydrochloride Tablets
Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.
Class II · Moderate risk
ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets
Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .
Class III · Low risk
Suprax (cefixime for oral suspension)
Discoloration; Product may not meet specifications for color description once reconstituted.
Class II · Moderate risk
Irinotecan Hydrochloride Injection
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
Class III · Low risk
Wal-Mart Equate Tussin CF Adult Maximum Strength
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Class III · Low risk
Select Brand Cough Control CF Max
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Class III · Low risk
Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Class III · Low risk
Well at Walgreens Wal-Tussin CF Max
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
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