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Class III: unlikely to cause harmTerminated

The Harvard Drug Group Gabapentin Tablets Recall

Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blis…

The Harvard Drug Group · La Vergne, TN

Risk level
Class III
Reported by FDA
May 17, 2023
Recall ID
D-0570-2023
Check your lot numberHow we source this data

Summary

The Harvard Drug Group recalled Gabapentin Tablets starting Apr 24, 2023. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0570-2023 on May 17, 2023. Reason: Product mixup: one foreign tablet found in product. Status: Terminated.

Why it was recalled

Product mixup: one foreign tablet found in product.

Product description

Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. East Windsor, NJ 08520 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA, NDC 0904-6823-61

Lot numbers, UPCs & expiration codes

Lot: T04468, Exp 10/2024

Where it was sold

USA Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0570-2023
Classification
Class III
Status
Terminated
Recall initiated
Apr 24, 2023
FDA report date
May 17, 2023
Quantity
3984 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
The Harvard Drug Group

Original FDA data

Every field from FDA enforcement report D-0570-2023, exactly as published.

Show all FDA fields
City
La Vergne
State
TN
Status
Terminated
Country
United States
Event ID
92174
Address
341 Mason Rd
Code information
Lot: T04468, Exp 10/2024
Postal code
37086-3606
Report date
May 17, 2023
Product type
Drugs
Recall number
D-0570-2023
Classification
Class III
Recalling firm
The Harvard Drug Group
Product quantity
3984 cartons
Termination date
Apr 30, 2024
Reason for recall
Product mixup: one foreign tablet found in product.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. East Windsor, NJ 08520 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA, NDC 0904-6823-61
Distribution pattern
USA Nationwide
Recall initiation date
Apr 24, 2023
Initial firm notification
Letter
Center classification date
May 10, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0570-2023, published May 17, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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