Class II · Moderate risk
Entecavir Tablets
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Entecavir Tablets 0.5 mg
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854. By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India. NDC 31722-833-30
Affected NDC
31722-0833-30
Compare with the code on your package — it is the most precise check available.
Drug: Entecavir
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Entecavir NDC 31722-0833 |
ANHYDROUS .5 mg/1 | Tablet Oral |
Camber Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Hetero USA Inc
- NDC code
- 31722-833-30
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1095-2017 · FDA notice
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.
Other Entecavir recalls
See all
Class II · Moderate risk
Entecavir Tablets
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Class II · Moderate risk
Entecavir Tablets
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Entecavir Tablets
Failed Impurity/Degradation Specifications
Class II · Moderate risk
Entecavir
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.
Other recalls by Hetero USA Inc
All 2017 recalls
Class II · Moderate risk
Pantoprazole Sodium Delayed Release Tablets USP 40mg
CGMP Deviations: Discoloration
Class III · Low risk
Acyclovir Tablets
Presence of Foreign Substance: human hair melded into tablet.
Class III · Low risk
Montelukast sodium tablets
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
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