The Recall Desk
SevereFDA (Drugs)·D-0923-2018·Announced 2018-07-25

La Vita Compounding Pharmacy Recalls Glutathione Injection Due to Sterility Concerns

La Vita Compounding Pharmacy is recalling 191 vials of Glutathione 200mg/mL Injection because production methods raised questions about the sterility of the drug product.

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, which corresponds to a Severe rating under the rubric for significant injury/property-damage reports or high-risk defects, even without explicit hospitalization reports in the text.

Plain-English summary

La Vita Compounding Pharmacy, LLC is recalling 191 vials of Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water), 30 mL vial, Rx only. The recall was initiated due to a lack of processing controls, specifically because the products were produced in a manner that calls into question the sterility of the drug product intended to be sterile.

The affected product was distributed to patients via patient-specific prescription only in California. The specific lots involved are 144326@3 (Expiration 07/10/2018) and 145953@2 (Expiration 08/05/2018).

Patients who have received this medication should contact their healthcare provider or the recalling firm at 858.453.2500 for further instructions on how to proceed.

The recalled product

Product
Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water), 30 mL vial, Rx only, la VITA Compounding Pharmacy, 858.453.2500
Affected units
191

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 (4)

  • Lot #: 144326@3
  • Exp 07/10/2018
  • 145953@2
  • Exp 08/05/2018

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 3 recalled by La Vita Compounding Pharmacy, LLC 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 3 products in this recall →