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Class III: unlikely to cause harmTerminated

Akorn Gabapentin Oral Solution Recall

Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only

Akorn Inc · Lake Forest, IL

Risk level
Class III
Reported by FDA
Jan 17, 2018
Recall ID
D-0211-2018
Check your lot numberHow we source this data

Summary

Akorn recalled Gabapentin Oral Solution starting Dec 15, 2017. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0211-2018 on Jan 17, 2018. Reason: CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer. Status: Terminated.

Why it was recalled

CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.

Product description

Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701. NDC: 50383-311-47

Lot numbers, UPCs & expiration codes

Batch# 359774; Exp. 09/02/19

Where it was sold

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-0211-2018
Classification
Class III
Status
Terminated
Recall initiated
Dec 15, 2017
FDA report date
Jan 17, 2018
Quantity
4,885 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Akorn Inc

Original FDA data

Every field from FDA enforcement report D-0211-2018, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
78730
Address
1925 W Field Ct Ste 300
Code information
Batch# 359774; Exp. 09/02/19
Postal code
60045-4862
Report date
Jan 17, 2018
Product type
Drugs
Recall number
D-0211-2018
Classification
Class III
Recalling firm
Akorn Inc
Product quantity
4,885 bottles
Termination date
Apr 10, 2019
Reason for recall
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701. NDC: 50383-311-47
Distribution pattern
Nationwide
Recall initiation date
Dec 15, 2017
Initial firm notification
Letter
Center classification date
Jan 8, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0211-2018, published Jan 17, 2018. 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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