Lannett Recalls Levetiracetam Oral Solution Due to Microbial Contamination
Lannett Company is recalling specific lots of Levetiracetam Oral Solution because testing found out-of-specification microbial counts.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 agency classification is FDA Class I, which mandates a severity score of at least 4 per the rubric.
Plain-English summary
Lannett Company, Inc. is recalling 16,668 bottles of Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) bottles. The product is prescription-only and was distributed nationwide within the United States. The specific lots affected are 2190A and 2191A, with an expiration date of 07/2021.
The recall was initiated because the product failed to meet specifications for Total Aerobic Microbial Count, indicating microbial contamination in the non-sterile product.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled description, it should be returned to the pharmacy or supplier for disposal or replacement.
The recalled product
- Product
- Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philadelphia, PA 19136, NDC 54838-0548-80
- Manufacturer
- Lannett Company, Inc.
- Category
- Drug — Anticonvulsant
- Hazard
- Affected units
- 16,668
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 (3)
- Lot #: 2190A
- 2191A
- Exp. Date 07/2021
Distribution
Distributed nationwide across the United States.
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