Silarx Lamivudine Oral Solution Recalled for Mismatched Expiration Dates
Silarx Pharmaceuticals is recalling 576 bottles of Lamivudine Oral Solution because the expiration date on the carton does not match the bottle label.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences, and the issue is a minor labeling discrepancy.
Plain-English summary
Silarx Pharmaceuticals, Inc. is recalling 576 bottles of Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces). The product is prescription-only and was distributed nationwide.
The recall was initiated after the firm received a customer complaint stating that the expiration date printed on the unit carton (5/18) does not match the expiration date on the bottle label (5/17). The affected product is identified by Lot # 0649A.
Consumers with this product should contact their healthcare provider or pharmacist for guidance on how to proceed.
The recalled product
- Product
- Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceuticals, Inc. Carmel, NY 10512, NDC 54838-0566-70
- Manufacturer
- Silarx Pharmaceutical, Inc.
- Category
- Drug — Antiviral
- Hazard
- Affected units
- 576
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 (1)
- Lot # 0649A Exp. Date 05/18 (unit carton)
Distribution
Distributed nationwide across the United States.
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