Class II · Moderate risk Ongoing
Entecavir Tablets
Reason Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Entecavir Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
What was recalled
Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- NDC code
- 68382-921-06
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0002-2026
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Entecavir recalls
See all
Class II · Moderate risk Ongoing
Entecavir Tablets
Reason Failed Impurity/Degradation Specifications
Class II · Moderate risk Ongoing
Entecavir Tablets
Reason Failed Impurity/Degradation Specifications
Class II · Moderate risk Terminated
Entecavir Tablets 0.5 mg
Reason Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Class II · Moderate risk Terminated
Entecavir
Reason Labeling: Label Mixup: ENTECAVIR, Tablet, 0.5 mg may be potentially mis-labeled as one of the following drugs: ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD30140_25, EXP: 5/7/2014; aMILoride HCl, Tablet, 5 mg, NDC 64980015101, Pedigree: W003686, EXP: 6/26/2014; ATOMOXETINE HCL, Capsule, 80 mg, NDC 00002325030, Pedigree: AD60272_49, EXP: 5/22/2014.
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