Reported Jun 10, 2020 · Terminated
Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50,…
AVKARE Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AVKARE Inc. · 615 N 1st St · Pulaski, TN · 38478-2403
Is this the product you have?
Lamotrigine TabletsUSP150 mgRx Onlya) 60 count BottleNDC 42291-368-60b) 500 count BottleNDC 42291-368-50
- Manufactured forAvKARE, Inc. Pulaski, TN 38478
- Lot codes and dates
Lot #: a) 25634b) 25633Exp. 09/30/2021
- Amount recalled
- 4124 bottles
Where it was sold
- Nationwide
Why it was recalled
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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