FDA-Drug2020-06-10Class III

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.

AVKARE Inc.
Hazard

Presence of Foreign Substance consistent with granules from desiccant packs used during storage

Sold states
Nationwide in the U.S.
Affected count
4124 bottles
Manufactured in
615 N 1st St, N/A, Pulaski, TN, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1289-2020

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