FDAFDA · Food and drugs·Recall number D-0135-2017
Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505
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 15 month timepoint.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Distributor
- Nationwide
- Lot
- Lot#: a) 3061779, Exp 11/16; 3071447, Exp 04/17; b)3071789, Exp 04/17
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.