The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1253-2019·Announced 2019-05-08

Customceutical Compounding Recalls BPlex Injectable Vials Due to Sterility Concerns

Customceutical Compounding is recalling 32 vials of BPlex injectable compound because the product lacks assurance of sterility. The recall covers products 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 and involves a lack of sterility assurance for injectable products, which poses a significant risk of infection and potential serious injury.

Plain-English summary

Customceutical Compounding is recalling 32 vials of BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML), 10 ML MULTIDOSE VIAL MDV INJ COMPOUNDED. The recall was initiated because the product lacks assurance of sterility for injectables and solutions intended to be sterile.

The affected product is identified by Lot # 02082019@9 and has an expiration date of 5/19/19. The recall covers products distributed nationwide in the U.S.A.

Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL 250MG/ML), 10 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
32

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 #: 02082019@9
  • Exp 5/19/19

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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