Class III
Terminated
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.
This recall has been terminated (originally issued June 10, 2020).
- Company
- Avkare Inc.
- Recall Initiated
- May 28, 2020
- Posted
- June 10, 2020
- Recall Number
- D-1289-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4124 bottles
- Firm Location
- Pulaski, TN, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Distribution
Nationwide in the U.S.
Lot / Code Info
Lot #: a) 25634, b) 25633; Exp. 09/30/2021
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