🔍 RecallPedia

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

Class I - Dangerous
💊 Drugs Recalled: December 15, 2017 Akorn Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Batch# 359774; Exp. 09/02/19
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Akorn Inc
Reason for Recall:
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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

Product Codes/Lot Numbers:

Batch# 359774; Exp. 09/02/19

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0211-2018

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