Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478.
Reported: June 10, 2020 Initiated: May 28, 2020 #D-1289-2020
Product Description
Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478.
Reason for Recall
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Details
- Recalling Firm
- AVKARE Inc.
- Units Affected
- 4124 bottles
- Distribution
- Nationwide in the U.S.
- Location
- Pulaski, TN
Frequently Asked Questions
What product was recalled? ▼
Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478.. Recalled by AVKARE Inc.. Units affected: 4124 bottles.
Why was this product recalled? ▼
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 10, 2020. Severity: Low. Recall number: D-1289-2020.
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