The Recall Desk
SevereFDA (Drugs)·D-1257-2019·Announced 2019-05-08

Customceutical Compounding Recalls Lipoplex Injectable Vials Due to Sterility Concerns

Customceutical Compounding is recalling 16 vials of Lipoplex injectable compound because the sterility of the product cannot be assured.

What this means for you

Illness, injury, or structural failure has been reported. 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, and the hazard involves a lack of sterility assurance for an injectable product, which poses a significant risk of serious injury or infection.

Plain-English summary

Customceutical Compounding is recalling 16 vials of Lipoplex, a compounded injectable solution containing methionine, inositol, choline chloride, hydroxocobalamin, dexpantenol, and pyridoxine HCl. The product is a 10 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 02212019@13, with an expiration date of 5/22/19. The product was distributed nationwide in the United States.

Consumers and healthcare providers who have this product should stop using it and contact the recalling firm or their healthcare provider for instructions on disposal or return.

The recalled product

Product
Lipoplex (METHIONINE 25 MG/ML INOSITOL 50 MG/ML CHOLINE CHLORIDE 50 MG/ML HYDROXOCOBALAMIN 500 MC/ML DEXPANTHENOL 50 MG/ML PYRIDOXINE HCL 50 MG/ML), 10 ML MULTIDOSE VIAL 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
16

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 #: 02212019@13
  • Exp 5/22/19

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 →

Related recalls

Same manufacturer · Customceutical Compounding

See all →

Same hazard · sterility

See all →