🔍 RecallPedia

CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01

Class I - Dangerous
💊 Drugs Recalled: June 1, 2016 Aidarex Pharmaceuticals Prescription Drugs

What Should You Do?

  1. Check if you have this product:
    Lot#: 47312-1, Exp 01/2018
  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:
Aidarex Pharmaceuticals LLC
Reason for Recall:
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01

Product Codes/Lot Numbers:

Lot#: 47312-1, Exp 01/2018

Distribution:

Distributed in: IN, GA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0974-2016

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