FDAFDA · Food and drugs·Recall number D-0136-2017
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
Published November 16, 2016 · Recall initiated: September 28, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Distributor
- Nationwide
- Lot
- Lot#: 3061784, Exp 11/16; 3067656, Exp 12/16; 3074902, Exp 08/17
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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