The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1255-2019·Announced 2019-05-08

Customceutical Compounding Recalls Glutathione Injection Vials Due to Sterility Concerns

Customceutical Compounding is recalling specific lots of compounded Glutathione 200mg/mL injection vials because the FDA could not ensure the products were sterile.

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, which corresponds to a Severe rating under the rubric. The hazard involves a lack of sterility assurance in an injectable product, which poses a significant risk of infection or serious injury.

Plain-English summary

Customceutical Compounding is voluntarily recalling four vials of compounded Glutathione 200mg/mL injection, available in 10 mL and 12 mL multidoses. The recall affects Lot # 02132019@25, which has an expiration date of May 14, 2019. The product was distributed nationwide in the United States.

The recall was initiated because the FDA identified a lack of assurance regarding the sterility of the injectable solution. For injectable medications, sterility is a critical safety requirement to prevent the introduction of harmful microorganisms into the body.

Consumers who possess this specific lot of Glutathione injection should stop using it immediately and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE VIAL MDV 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
4

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 #: 02132019@25
  • Exp 5/14/19

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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