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
Reported: May 8, 2019 Initiated: April 8, 2019 #D-1261-2019
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
Reason for Recall
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Details
- Recalling Firm
- Customceutical Compounding
- Units Affected
- 3 vials
- Distribution
- U.S.A. Nationwide
- Location
- Phoenix, AZ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Customceutical Compounding. Units affected: 3 vials.
Why was this product recalled? ▼
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 8, 2019. Severity: Moderate. Recall number: D-1261-2019.
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