Gabapentin tablets recalled due to product mixup with foreign tablet
The Harvard Drug Group recalled 3,984 cartons of Gabapentin 600 mg tablets distributed nationwide due to a product mixup where one foreign tablet was found.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: FDA Class III recalls are typically scored 1 or 2. This recall involves a single foreign tablet representing low-risk contamination with no reported illnesses or injuries.
Plain-English summary
The Harvard Drug Group is recalling 3,984 cartons of Gabapentin 600 mg tablets due to a product mixup where one foreign tablet was found in the product. The affected tablets are distributed nationwide.
The recalled product is identified by lot T04468 with an expiration date of October 2024 and NDC code 0904-6823-61. This is a prescription medication distributed by Aurobindo Pharma USA, Inc. and Major Pharmaceuticals.
Consumers who have received the recalled product should not use it and should contact their healthcare provider or pharmacist regarding the recall. Patients should consult their healthcare provider about obtaining replacement medication if needed.
The recalled product
- Product
- GABAPENTIN (GABAPENTIN)
- Brand
- GABAPENTIN
- Manufacturer
- The Harvard Drug Group
- Category
- Drug — Prescription Medication
- Affected units
- 3,984
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 (2)
- Lot: T04468
- Exp 10/2024
Distribution
Distributed nationwide across the United States.
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