The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1256-2019·Announced 2019-05-08

Customceutical Compounding Recalls HCG Injection Vials Due to Sterility Concerns

Customceutical Compounding is recalling 12 vials of compounded HCG injection due to a lack of assurance of sterility. The product was 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 an injectable product, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.

Plain-English summary

Customceutical Compounding is recalling 12 vials of compounded HCG (Chorionic Gonadotropin 1000 IU/mL PEP 25 mg/mL) injection, 5 mL multidose vials. The recall is being conducted because of a lack of assurance of sterility for injectables and solutions intended to be sterile.

The affected product is identified by Lot # 03132019@23 and has an expiration date of 5/12/19. The recall covers distribution across the United States nationwide.

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

The recalled product

Product
HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL) inj 5 mL multidose vial 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
12

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 #: 03132019@23
  • Exp 5/12/19

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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