🔍 RecallPedia

Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01

Class I - Dangerous
💊 Drugs Recalled: April 24, 2018 Mylan Pharmaceuticals Prescription Drugs

What Should You Do?

  1. Check if you have this product:
    Lot Numbers# 3083005, 3083006, 3086121, and 3086122, exp Jan 2019
  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:
Mylan Pharmaceuticals Inc.
Reason for Recall:
cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01

Product Codes/Lot Numbers:

Lot Numbers# 3083005, 3083006, 3086121, and 3086122, exp Jan 2019

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0819-2018

Related Recalls