Levetiracetam Oral Solution Recalled Due to Foreign Screw Presence
Hetero Labs is recalling Levetiracetam Oral Solution because a foreign substance, specifically a screw, was found in the product.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a foreign object (screw) in an oral medication, which poses a risk of harm (choking or injury) even though no specific injuries are reported in the source text, fitting the 'High' criteria for risk-of-harm products.
Plain-English summary
Hetero Labs, Ltd. - Unit III is recalling 4,050 bottles of Levetiracetam Oral Solution, USP, 100 mg/mL, 16 fl oz (473 mL). The product is a prescription-only medication manufactured for Camber Pharmaceuticals, Inc. The specific lot affected is # E170346 with an expiration date of 02/19.
The recall was initiated because a foreign substance, identified as a screw, was found in the product. The distribution of the affected units was limited to New Jersey (NJ).
Consumers who have this specific lot of Levetiracetam Oral Solution should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- LEVETIRACETAM (LEVETIRACETAM ORAL)
- Brand
- LEVETIRACETAM
- Manufacturer
- Hetero Labs, Ltd. - Unit III
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 4,050
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 # E170346
- Exp 02/19
UPCs (1)
- 0331722574471
Distribution
Distributed in 1 state:
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