The Recall Desk
LowFDA (Drugs)·D-0136-2017·Announced 2016-11-16

Mylan Recalls Clonazepam Tablets Due to Impurity Specification Failure

Mylan Institutional is recalling specific lots of Clonazepam 1.0 mg tablets because a known impurity exceeded specification limits during stability testing.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling Clonazepam Tablets, USP, 1.0 mg, packaged in 100-count unit dose boxes. The affected product is identified by NDC 51079-882-20 and includes lot numbers 3061784 (Exp 11/16), 3067656 (Exp 12/16), and 3074902 (Exp 08/17). The recall involves 46,472 unit dose blister cards.

The recall was initiated due to a failed impurities/degradation specification. Specifically, an out-of-specification result was found for Clonazepam Related Compound (RC) A, a known impurity, at the 16-month timepoint. The product was distributed nationwide.

The U.S. Food and Drug Administration has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Patients and healthcare providers should check their inventory for the specific lot numbers listed above and contact Mylan Institutional or their healthcare provider for further instructions regarding replacement or disposal.

The recalled product

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
Manufacturer
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Category
Drug — Prescription Medication
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Lot#: 3061784
  • Exp 11/16
  • 3067656
  • Exp 12/16
  • 3074902
  • Exp 08/17

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories) under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

See all →

Same hazard · impurity

See all →