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Class II: temporary or reversible health riskTerminated

Downing Labs EDTA Disodium Injectable Recall

EDTA Disodium Injectable, 150mg/mL, 100mL vial, Rx only, Downing Labs, LLC 4001 McEwen…

Downing Labs, LLC · Dallas, TX

Risk level
Class II
Reported by FDA
Nov 25, 2015
Recall ID
D-0340-2016
Check your lot numberHow we source this data

Summary

Downing Labs recalled EDTA Disodium Injectable starting Oct 16, 2015. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0340-2016 on Nov 25, 2015. Reason: Lack of Assurance of Sterility. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility

Product description

EDTA Disodium Injectable, 150mg/mL, 100mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

Lot numbers, UPCs & expiration codes

All lots

Where it was sold

Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0340-2016
Classification
Class II
Status
Terminated
Recall initiated
Oct 16, 2015
FDA report date
Nov 25, 2015
Quantity
2279 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Downing Labs, LLC

Original FDA data

Every field from FDA enforcement report D-0340-2016, exactly as published.

Show all FDA fields
City
Dallas
State
TX
Status
Terminated
Country
United States
Event ID
72455
Address
4001 McEwen Rd Suite 110
Code information
All lots
Postal code
75244-5020
Report date
Nov 25, 2015
Product type
Drugs
Recall number
D-0340-2016
Classification
Class II
Recalling firm
Downing Labs, LLC
Product quantity
2279 vials
Termination date
Sep 22, 2016
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
EDTA Disodium Injectable, 150mg/mL, 100mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Distribution pattern
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan
Recall initiation date
Oct 16, 2015
Initial firm notification
Press Release
Center classification date
Nov 18, 2015

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0340-2016, published Nov 25, 2015. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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