FDA recall D-1847-2019

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

Reason for recall

Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths section of the insert that incorrectly lists the tablet description coding for the tablets.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2019-08-27

Report date

2019-09-18

Termination date

2020-09-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1847-2019