American Health Packaging Recalls Lamivudine and Zidovudine Tablets for Dissolution Failure
American Health Packaging is recalling 925 cartons of Lamivudine and Zidovudine Tablets USP 150mg/300mg 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 due to failed dissolution specifications, which is a quality control issue that may affect drug efficacy but is not associated with reported serious injuries or fatalities in the source text.
Plain-English summary
American Health Packaging is recalling 925 cartons of Lamivudine and Zidovudine Tablets USP 150mg/300mg, 30 Unit Dose Blisters. The product is prescription-only and was distributed nationwide. The specific lot number is 140849, with NDC 68084-0416-21 for the carton and NDC 68084-0416-11 for the individual dose.
The recall was initiated because the tablets failed to meet dissolution specifications. Dissolution is a critical quality attribute that ensures the medication releases its active ingredients at the appropriate rate in the body. Failure to meet these specifications may result in the medication not working as intended.
Healthcare providers and patients should stop using the affected product and contact their pharmacist or prescriber for guidance on obtaining a replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton of 30: NDC 68084-0416-21, Individual dose: NDC 68084-0416-11
- Manufacturer
- American Health Packaging
- Category
- Drug — Antiretroviral
- Hazard
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 #140849
Distribution
Distributed nationwide across the United States.
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