Reported Aug 17, 2022 · Terminated
Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC…
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 Tablets, USP 100 mg, 1000-count bottles, Rx Only
- Manufactured for
AvKAREInc. PulaskiTN 38478NDC 42291-367-10UPC 3 42291 36710 4
- Lot codes and dates
Lot #: 42581 Exp. 12/202442484 Exp. 11/202441204 Exp. 05/202438723 Exp. 02/202337623 Exp. 10/2022
- Amount recalled
- 8328 bottles
Where it was sold
- Nationwide
Why it was recalled
Labeling: Label Error on Declared Strength
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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