Amerisource Recalls Levofloxacin Tablets Due to Dissolution Failures
Amerisource Health Services is recalling 3,888 cartons of Levofloxacin 500 mg tablets because they failed dissolution specifications.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Amerisource Health Services is recalling 3,888 cartons of Levofloxacin Tablets USP, 500 mg. The product is packaged in 100-count blister cards and is identified by NDC 68084-482-01, Lot # 151387, and an expiration date of 10/31/16.
The recall was initiated because the tablets produced unexplained low out-of-specification results for dissolution. This means the tablets may not dissolve at the required rate, potentially affecting how the medication is absorbed in the body.
The affected product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or further instructions.
The recalled product
- Product
- Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister cards per carton, individual blisters labeled UPC (01) 003 68084 482 11 3, carton labeled NDC 68084-482-01, UPC (01) 0 03 68084 482 01 4; Rx only, Packaged and Distributed by: American Health Packaging…
- Manufacturer
- Amerisource Health Services
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 3,888
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 # 151387
- Exp 10/31/16
Distribution
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