Entecavir Tablets 0.5 mg recall: Impurity Out of Spec
Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854. By: Hetero Labs…
Why was Entecavir Tablets 0.5 mg recalled?
Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # ENT17008, Exp 01/2019
- Product
- Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854. By: Hetero Labs…
- Recalling firm
- Hetero USA Inc
- Quantity
- 5664 bottles
- Distribution
- NJ
- Recall date
- August 23, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)