Class II · Moderate risk
Wockhardt Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.
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
Orphenadrine Citrate Extended Release Tablets
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Class III · Low risk
Aspirin DR Enteric Coated Tablets
Failed Dissolution Specification; at the 12 month time interval.
Class II · Moderate risk
Bystolic (nebivolol)
Failed Dissolution Specifications: Drug failed stage III dissolution testing.
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
Class II · Moderate risk
Dr. Reddy's Metoprolol Succinate Extended Release Tablets
Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.
Class II · Moderate risk
Isoniazid Tablets
Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.
Class II · Moderate risk
Bystolic (nebivolol)
Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout the product's shelf life.
Class III · Low risk
Wockhardt Metoprolol Succinate
Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications: Failure of dissolution test observed at three month time point.
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Class II · Moderate risk
Venlafaxine Hydrochloride Extended-Release Tablets
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Class III · Low risk
Venlafaxine Hydrochloride
Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.
Class II · Moderate risk
Alprazolam Extended-Release Tablets
Failed Dissolution Specifications: Product did not meet specification requirements for dissolution.
Class II · Moderate risk
Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP
Failed Dissolution Specification; 12-Month stability interval.
Class II · Moderate risk
Pyridostigmine Bromide Tablets USP
Failed Dissolution Specification: Corepharma Inc. is recalling Pyridostigmine Bromide Tablets USP 60 mg due to an out of specification dissolution test generated at the 30 month stability time point.
Class II · Moderate risk
Pantaprazole Sodium Delayed Release Tablets
Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.
Class III · Low risk
BuPROPion Hydrochloride Extended-Release Tablet
Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.
Class III · Low risk
Namenda XR
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Class III · Low risk
Namenda XR
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Class III · Low risk
Namenda XR
Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.
Class III · Low risk
Glipizide XL
Failed Dissolution Specification; the bulk lot yielded an out of specification result at the 8 hr timepoint, 18 month interval
Class III · Low risk
Glucotrol XL
Failed Dissolution Specification; 8 hr stability timepoint
Class II · Moderate risk
Dexedrine¿
Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 month CRT Stability Level.
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