Clonazepam Tablets recall: Impurity Out of Spec
Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, NDC 51079-882-20
Why was Clonazepam Tablets recalled?
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
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#: 3061784, Exp 11/16; 3067656, Exp 12/16; 3074902, Exp 08/17
- Product
- Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, NDC 51079-882-20
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Quantity
- 46,472 unit dose blister cards (10 cards of 10 tablets each)
- Distribution
- Nationwide
- Recall date
- November 16, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)