ATROPINE SULFATE 0.01% OPHTH, Ophthalmic, 0.01%, Rx only, 15 mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot # 01-20-2017@17, Exp 4/20/2017; 01-23-2017@48, Exp 4/23/2017; 01-27-2017@17, Exp 4/27/2017; 01-31-2017@42, Exp 5/1/2017; 02-01-2017@35, Exp 5/2/2017; t02-07-2017@67, Exp 5/9/2017.
  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:
Key Pharmacy and Compounding Center
Reason for Recall:
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

ATROPINE SULFATE 0.01% OPHTH, Ophthalmic, 0.01%, Rx only, 15 mL Glass /Multiple Dose vial, Prepared by Key Compounding Pharmacy

Product Codes/Lot Numbers:

Lot # 01-20-2017@17, Exp 4/20/2017; 01-23-2017@48, Exp 4/23/2017; 01-27-2017@17, Exp 4/27/2017; 01-31-2017@42, Exp 5/1/2017; 02-01-2017@35, Exp 5/2/2017; t02-07-2017@67, Exp 5/9/2017.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0711-2017

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