Drug recall D-1289-2020
Product
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
Lots and codes
Lot #: a) 25634, b) 25633; Exp. 09/30/2021
Recall details
- Recalling firm
- AVKARE Inc., Pulaski, TN
- Quantity
- 4124 bottles
- Distribution
- Nationwide in the U.S.
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 28, 2020
- Terminated
- October 22, 2021
Related products
- Lamotrigine – drug information
- NDC 42291-369 Lamotrigine · Lamotrigine 200 mg/1 · AvKARE
- NDC 42291-366 Lamotrigine · Lamotrigine 25 mg/1 · AvKARE
- NDC 42291-368 Lamotrigine · Lamotrigine 150 mg/1 · AvKARE
- NDC 42291-367 Lamotrigine · Lamotrigine 100 mg/1 · AvKARE