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Class II: temporary or reversible health riskTerminated

Assurance Infusion Trimix Super Recall

TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

Assurance Infusion · Houston, TX

Risk level
Class II
Reported by FDA
Jan 22, 2020
Recall ID
D-0779-2020
Check your lot numberHow we source this data

Summary

Assurance Infusion recalled Trimix Super starting Dec 20, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0779-2020 on Jan 22, 2020. Reason: Lack of sterility assurance. Status: Terminated.

Why it was recalled

Lack of sterility assurance.

Product description

TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800

Lot numbers, UPCs & expiration codes

Lots: 10152019@23 Exp. 03/04/2020; 10302019@27 Exp. 04/27/2020; 08052019@19 Exp. 02/01/2020; 10032019@14 Exp. 03/31/2020

Where it was sold

Nationwide within the United States

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-0779-2020
Classification
Class II
Status
Terminated
Recall initiated
Dec 20, 2019
FDA report date
Jan 22, 2020
Quantity
45 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Assurance Infusion

Original FDA data

Every field from FDA enforcement report D-0779-2020, exactly as published.

Show all FDA fields
City
Houston
State
TX
Status
Terminated
Country
United States
Event ID
84546
Address
2626 S Loop W Ste 555
Code information
Lots: 10152019@23 Exp. 03/04/2020; 10302019@27 Exp. 04/27/2020; 08052019@19 Exp. 02/01/2020; 10032019@14 Exp. 03/31/2020
Postal code
77054-2652
Report date
Jan 22, 2020
Product type
Drugs
Recall number
D-0779-2020
Classification
Class II
Recalling firm
Assurance Infusion
Product quantity
45 vials
Termination date
Oct 27, 2021
Reason for recall
Lack of sterility assurance.
Voluntary / mandated
Voluntary: Firm initiated
Product description
TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800
Distribution pattern
Nationwide within the United States
Recall initiation date
Dec 20, 2019
Initial firm notification
Letter
Center classification date
Jan 13, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0779-2020, published Jan 22, 2020. 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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