FDA-Drug2021-06-02Class II

Lamotrigine Extended-Release Tablets 250 mg 30 Tablets Rx Only NDC 49884-604-11 Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Zhejiang 317024 China For Par Pharmaceutical Companes, Inc. Spring Valley, NY 10977 U.S.A.

Cardinal Health Inc.
Hazard

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Sold states
FL, GA, SC
Affected count
131 bottles
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Products
Lamotrigine Extended-Release Tablets 250 mg 30 Tablets Rx Only NDC 49884-604-11 Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Zhejiang 317024 China For Par Pharmaceutical Companes, Inc. Spring Valley, NY 10977 U.S.A.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0538-2021

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