Mylan Recalls Levetiracetam Tablets Due to Foreign Tablet Presence
Mylan Pharmaceuticals is recalling 960 bottles of Levetiracetam 500 mg tablets because foreign tablets may have been distributed in the bottles.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury/property-damage reports or high-risk scenarios.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling 960 bottles of Levetiracetam Tablets, USP 500 mg. The recall was initiated because the manufacturer may have distributed foreign tablets in bottles of the medication.
The affected product is identified by Lot ZLMM12063 with an expiration date of March 2014. The product was distributed to Kentucky. This is a prescription-only medication manufactured for Mylan Pharmaceuticals Inc. in Morgantown, WV.
Consumers who have this specific lot of Levetiracetam should stop using it and contact their healthcare provider or pharmacist for guidance on how to dispose of the product or obtain a replacement.
The recalled product
- Product
- LEVETIRACETAM (LEVETIRACETAM)
- Brand
- LEVETIRACETAM
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 960
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 ZLMM12063
- Exp March 2014
Distribution
Distributed in 1 state:
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