Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Dissolution Testing: Failed 24 month dissolution testing.
Cause type: 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. All dissolution failure recalls.
univasc (moexipril HCl) tablets, 7.5 mg, 100 Ct Bottle, Rx Only. Manufactured for UCB, Inc., Smyrna, GA 30080. NDC: 0091-3707-01.
Compare with the code on your package — it is the most precise check available.
Drug: Moexipril
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.
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.
Failed Dissolution Specifications.
Failed Dissolution Specifications: low test results at the 18 month time-point
Failed Dissolution Specification
Failed Dissolution Specifications: Low Out-of-Specification results for the 8 hour timepoint.
Failed Dissolution Specifications: Failed 24 month dissolution testing.
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