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
Reported: August 17, 2022 Initiated: July 20, 2022 #D-1329-2022
Product Description
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
Reason for Recall
Labeling: Label Error on Declared Strength
Details
- Recalling Firm
- AVKARE Inc.
- Units Affected
- 8328 bottles
- Distribution
- Nationwide within the United States
- Location
- Pulaski, TN
Frequently Asked Questions
What product 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. Recalled by AVKARE Inc.. Units affected: 8328 bottles.
Why was this product recalled? ▼
Labeling: Label Error on Declared Strength
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 17, 2022. Severity: Low. Recall number: D-1329-2022.
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