Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston TX 77054. NDC 4252-401-10

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot # 5/7/18 7482 40110P, BUD 9/4/2018; 5/22/18 0804 40110P, BUD 9/19/2018; 5/3/18 1111 40110P, BUD 8/31/2018.
  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:
Avella of Deer Valley, Inc. Store 38
Reason for Recall:
Lack of Assurance of Sterility: Potential leakage of bags.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston TX 77054. NDC 4252-401-10

Product Codes/Lot Numbers:

Lot # 5/7/18 7482 40110P, BUD 9/4/2018; 5/22/18 0804 40110P, BUD 9/19/2018; 5/3/18 1111 40110P, BUD 8/31/2018.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-0937-2018

Related Recalls

Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.

Feb 8, 2019 Compounded Drugs View Details →