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Class II: temporary or reversible health riskTerminated

Customceutical Compounding Trimix HIGH Recall

Trimix HIGH (Papaverine HCl 30 mg/mL Phentolamine Mesylate 2 mg/mL Alprostadil 20 mcg/m…

Customceutical Compounding · Phoenix, AZ

Risk level
Class II
Reported by FDA
May 8, 2019
Recall ID
D-1261-2019
Check your lot numberHow we source this data

Summary

Customceutical Compounding recalled Trimix HIGH starting Apr 8, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1261-2019 on May 8, 2019. Reason: Lack of assurance of sterility for injectables and solutions intended to be sterile. Status: Terminated.

Why it was recalled

Lack of assurance of sterility for injectables and solutions intended to be sterile.

Product description

Trimix HIGH (Papaverine HCl 30 mg/mL Phentolamine Mesylate 2 mg/mL Alprostadil 20 mcg/mL), 2 mL multidose vial MDV Inj. Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272

Lot numbers, UPCs & expiration codes

Lot #: 02182019@27, Exp 8/02/19

Where it was sold

U.S.A. Nationwide

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-1261-2019
Classification
Class II
Status
Terminated
Recall initiated
Apr 8, 2019
FDA report date
May 8, 2019
Quantity
3 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Customceutical Compounding

Original FDA data

Every field from FDA enforcement report D-1261-2019, exactly as published.

Show all FDA fields
City
Phoenix
State
AZ
Status
Terminated
Country
United States
Event ID
82615
Address
4611 E Shea Blvd Bldg 3 Ste 180
Code information
Lot #: 02182019@27, Exp 8/02/19
Postal code
85028-4258
Report date
May 8, 2019
Product type
Drugs
Recall number
D-1261-2019
Classification
Class II
Recalling firm
Customceutical Compounding
Product quantity
3 vials
Termination date
May 19, 2023
Reason for recall
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Trimix HIGH (Papaverine HCl 30 mg/mL Phentolamine Mesylate 2 mg/mL Alprostadil 20 mcg/mL), 2 mL multidose vial MDV Inj. Compounded. Customceutical Compounding 4611 E. Shea Blvd. Bldg 3 180, Phoenix, AZ 85028 Ph. 480 516 0272
Distribution pattern
U.S.A. Nationwide
Recall initiation date
Apr 8, 2019
Initial firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Center classification date
Apr 30, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1261-2019, published May 8, 2019. 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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