Clonazepam Orally Disintegrating Tablets recall: Impurity Out of Spec
Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC…
Why was Clonazepam Orally Disintegrating Tablets recalled?
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
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 #: AA84106, Exp 9/2021
- Product
- Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC…
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Quantity
- 3516 bottles
- Distribution
- Nationwide USA
- Recall date
- August 5, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)