AVKARE Inc. recalls Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 422…
- Recall date
- July 20, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1329-2022
- FDA classification
- Class III
- Brand / firm
- AVKARE Inc.
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Labeling: Label Error on Declared Strength
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4
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