Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP
Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
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.
Moexipril HCl Tablets 7.5mg, 100 tabs, Rx Only, Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0110-01 ,
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.
Failed Dissolution Testing: Failed 24 month dissolution testing.
Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.
Presence of Particulate Matter Perrigo is recalling seven lots of Clindamycin Palmitate Hydrochloride for Oral Solution 75mg/5ml.
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%).
Failed Dissolution Specifications; 36 month stability timepoint
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
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