AvKARE Recalls Lamotrigine Tablets Due to Foreign Substance Presence
AvKARE Inc. is recalling 4,124 bottles of Lamotrigine 150 mg tablets because they contain foreign substance consistent with desiccant pack granules.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low probability of adverse health consequences. The hazard involves foreign substance contamination (desiccant granules) without reported injuries or illnesses, fitting the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
AvKARE Inc. is recalling 4,124 bottles of Lamotrigine Tablets, USP, 150 mg, Rx Only. The affected products are distributed nationwide in the U.S. and include 60-count bottles (NDC 42291-368-60) and 500-count bottles (NDC 42291-368-50). The specific lots involved are 25634 and 25633, both with an expiration date of 09/30/2021.
The recall was initiated due to the presence of a foreign substance consistent with granules from desiccant packs used during storage. This contamination occurred during the storage process for the medication.
Patients and healthcare providers should check their inventory for these specific lot numbers and NDC codes. If found, the medication should be discontinued and returned to the pharmacy or supplier for disposal or replacement. No specific instructions for immediate medical action are provided in the source text, but patients should consult their healthcare provider if they have concerns regarding the use of the affected product.
The recalled product
- Product
- LAMOTRIGINE (LAMOTRIGINE)
- Brand
- LAMOTRIGINE
- Manufacturer
- AVKARE Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 4,124
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: a) 25634
- b) 25633
- Exp. 09/30/2021
UPCs (1)
- 0342291368606
Distribution
Distributed nationwide across the United States.
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