Mylan Recalls Clonazepam Tablets Due to Impurity Specification Failure
Mylan Institutional, Inc. is recalling Clonazepam Tablets, 0.5 mg, because a known impurity exceeded specifications at the 6-month timepoint.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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 unlikely to cause adverse health consequences, and no illnesses or injuries are reported in the source text.
Plain-English summary
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling Clonazepam Tablets, USP, 0.5 mg, 100-count cartons. The recall involves 868 unit cartons, totaling 86,800 tablets, distributed nationwide. The specific lot affected is #3063759, with an expiration date of 07/16.
The recall was initiated due to a failed impurities/degradation specification. Specifically, the product yielded an out-of-specification result for a known impurity at the 6-month timepoint. This is classified as an FDA Class III recall.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on alternative treatments. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21
- 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 (2)
- Lot # 3063759
- Exp.07/16
Distribution
Distributed nationwide across the United States.
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