Montelukast sodium tablets recall
Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETERO Labs…
Why was Montelukast sodium tablets recalled?
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
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 # MON16001B, Exp 01/18
- Product
- Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETERO Labs…
- Recalling firm
- Hetero USA Inc
- Quantity
- 65,664 bottles
- Distribution
- US Nationwide
- Recall date
- April 5, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)