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.
What this means for you
Illness, injury, or structural failure has been reported. 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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