The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1261-2019·Announced 2019-05-08

Customceutical Compounding Recalls Trimix HIGH Vials Due to Sterility Concerns

Customceutical Compounding is recalling Trimix HIGH injectable vials because the company cannot ensure the product is sterile. The recall covers 3 vials distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant risk of harm (lack of sterility in an injectable) corresponds to a Severe severity score.

Plain-English summary

Customceutical Compounding is recalling 3 vials of Trimix HIGH, a compounded injectable solution containing Papaverine HCl, Phentolamine Mesylate, and Alprostadil. The product is a 2 mL multidose vial intended for injection.

The recall was initiated due to a lack of assurance of sterility for the injectable solution. The specific lot number is 02182019@27, with an expiration date of 8/02/19. The product was distributed nationwide in the United States.

Consumers who possess this specific lot of Trimix HIGH should stop using the product immediately and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.

The recalled product

Product
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
Manufacturer
Customceutical Compounding
Category
Drug — Compounded Injectable
Hazard
Affected units
3

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by Customceutical Compounding under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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