Class III · Low risk
Venlafaxine
Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose.
405 FDA drug recalls with this cause, newest first.
These recalls happen when a tablet or capsule does not dissolve the way its specification requires. Because dissolution controls how the drug is released, a failure can mean a patient absorbs it too slowly, too quickly, or not at all - a particular concern for extended-release products, where the release profile is the whole point.
Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: This recall is an extension of the recall initiated on 07/31/2013 for Bupropion HCl Extended-Release Tablets (XL) 300 mg, because another lot was shown to have similar failing results for dissolution at the 8-hour timepoint.
Class II · Moderate risk
Extended Phenytoin Sodium Capsules
Failed dissolution specifications; 18 month CRT
Class III · Low risk
BuPROPion Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
Class II · Moderate risk
Methylphenidate Hydrochloride Extended-Release Capsules
Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
Class II · Moderate risk
Methylphenidate Hydrochloride Extended-Release Capsules
Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
Class II · Moderate risk
Methylphenidate Hydrochloride Extended-Release Capsules
Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
Class III · Low risk
Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate)
Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the specification for conjugated estrogens dissolution.
Class III · Low risk
Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate)
Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the dissolution specification for conjugated estrogens.
Class III · Low risk
Norpace CR
Failed Dissolution Specification
Class II · Moderate risk
Actiq (oral transmucosal fentanyl citrate)
Failed Dissolution Specification; during stability testing
Class III · Low risk
Budesonide Capsules
Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
Class III · Low risk
buPROPion Hydrochloride Extended-Release Tablets
Failed USP Dissolution Test Requirements: Out-of-specification dissolution results at the 8 hour stability testing point.
Class III · Low risk
Dextroamphetamine Saccharate
Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.
Class III · Low risk
buPROPion Hydrochloride Extended Release Tablets
Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Class III · Low risk
buPROPion Hydrochloride Extended - Release Tablets
Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.
Class II · Moderate risk
Taztia XT
Failed Dissolution Specification: Out of a specification result occurred during the 3-month stability testing. Dissolution result at the 4-hour time point was 41% (specification: 20-40%).
Class II · Moderate risk
Isoniazid Tablets 300 mg tablets USP
Failed Dissolution Specifications; 36 month stability timepoint
Class II · Moderate risk
Dextroamphetamine Sulfate Extended Release Capsules
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Class II · Moderate risk
Dextroamphetamine Sulfate Extended Release Capsules
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Class II · Moderate risk
Dextroamphetamine Sulfate Extended Release Capsules
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Class II · Moderate risk
Propranolol Hydrochloride Extended-release Capsules
Failed Dissolution Test Requirements
Class II · Moderate risk
QUETIAPINE Fumarate Tablets 25mg 100 Tablets
Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Class II · Moderate risk
Moexipril HCl Tablets 7.5mg
Paddock Laboratories, LLC are recalling one lot (2012028142) of Moexipril HCl Tablets 7.5mg (expiration 1/2014) because of a non-conformity dissolution failure result found during routine stability testing at the 6 month test interval.
Class II · Moderate risk
Dr. Reddy's Quetiapine Fumarate Tablets
Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
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