🔍 RecallPedia

Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

Class I - Dangerous
💊 Drugs Recalled: April 12, 2019 CMC Enterprise Pharmacy Compounded Drugs

What Should You Do?

  1. Check if you have this product:
    Lots: EA141908 Exp. 4/14/2019; EA171909 Exp. 4/17/2019; EA211906 Exp. 4/21/2019; EA251908 Exp. 4/25/2019; EB041905 Exp. 5/6/2019; EB071907 Exp. 5/8/2019; EB151909 Exp. 5/16/2019; EC041906 Exp. 6/2/2019; EC111907 Exp. 6/9/2019; EC181908 Exp. 6/16/2019; EC201907 Exp. 6/18/2019
  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:
CMC Enterprise Pharmacy
Reason for Recall:
Lack of sterility assurance.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.

Product Codes/Lot Numbers:

Lots: EA141908 Exp. 4/14/2019; EA171909 Exp. 4/17/2019; EA211906 Exp. 4/21/2019; EA251908 Exp. 4/25/2019; EB041905 Exp. 5/6/2019; EB071907 Exp. 5/8/2019; EB151909 Exp. 5/16/2019; EC041906 Exp. 6/2/2019; EC111907 Exp. 6/9/2019; EC181908 Exp. 6/16/2019; EC201907 Exp. 6/18/2019

Distribution:

Distributed in: NC

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1209-2019

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