The Recall Desk
LowFDA (Drugs)·D-0135-2017·Announced 2016-11-16

Mylan Recalls Clonazepam Tablets Due to Impurity Specification Failure

Mylan Institutional, Inc. is recalling specific lots of Clonazepam Tablets, USP, 0.5 mg because they failed impurity specifications.

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 recall is classified as FDA 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, 0.5 mg, packaged in 100-count and 300-count unit dose boxes. The recall involves specific lots of the medication manufactured by Mylan Pharmaceuticals Inc. in Morgantown, WV.

The recall was initiated because the product failed impurities/degradation specifications. Specifically, there was an out-of-specification result for Clonazepam Related Compound (RC) A, a known impurity, at the 15-month timepoint. The affected lots are 3061779 (Exp 11/16), 3071447 (Exp 04/17), and 3071789 (Exp 04/17).

The recall is classified as FDA Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If found, the product should be returned to the distributor or pharmacy for credit.

The recalled product

Product
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
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 (5)

  • Lot#: a) 3061779
  • Exp 11/16
  • 3071447
  • Exp 04/17
  • b)3071789

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)

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Same hazard · impurity

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