Lamivudine Tablets Recalled for Incorrect Package Insert Labeling
American Health Packaging is recalling Lamivudine Tablets due to an error in the package insert that incorrectly lists tablet description coding.
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 by definition is unlikely to cause adverse health consequences, and the issue is a minor labeling error regarding tablet description coding.
Plain-English summary
American Health Packaging is recalling 60 cartons of Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters. The product is identified by NDC 60687-362-21 (Individual Dose NDC: 60687-362-11) and was distributed nationwide. The specific lots affected are 186509 and 186982, with an expiration date of 6/30/2021.
The recall was initiated due to a labeling error in the package insert. Specifically, the 'Dosage Forms and Strengths' section incorrectly lists the tablet description coding for the tablets. This is a Class III recall, indicating that the labeling error is unlikely to cause adverse health consequences.
Consumers and healthcare providers should check their inventory for these specific lot numbers and NDC codes. If the product is found, it should be returned to the distributor or the recalling firm, American Health Packaging, in Columbus, OH.
The recalled product
- Product
- Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, NDC 60687-362-21 (Individual Dose NDC: 60687-362-11), Distributed by American Health Packaging, Columbus, OH
- Manufacturer
- American Health Packaging
- Category
- Drug — Antiviral
- Hazard
- Affected units
- 60
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)
- Lots 186509 and 186982
- exp 6/30/2021
Distribution
Distributed nationwide across the United States.
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