The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1068-2018·Announced 2018-08-15

Guardian Pharmacy Recalls Glutathione Vials Due to Sterility Concerns

Guardian Pharmacy Services is recalling specific lots of compounded Glutathione 200 mg/mL vials in Texas due to a lack of sterility assurance.

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. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable compounds) are categorized as Severe (Score 4), as they are not Class I but represent a significant risk.

Plain-English summary

Guardian Pharmacy Services is recalling 100 50-ml vials of compounded Glutathione 200 mg/mL. The product is prescription-only and was distributed in Texas. The recall is being conducted because of a lack of sterility assurance.

The affected lots are identified by the following codes and use-by dates: Lot 58653:42 (Use By 06/12/2018), Lot 58773/58766 (Use By 06/21/2018), and Lot 58766:42 (Use By 06/20/2018). The product was compounded by Guardian Pharmacy Services located in Dallas, Texas.

Patients who have received this medication should contact their healthcare provider or pharmacist for guidance on what to do next. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247
Manufacturer
Guardian Pharmacy Services
Category
Drug — Compounded Injectable
Hazard

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 (3)

  • Lot: 58653:42 Use By: 06/12/2018
  • 58773/58766 Use By: 06/21/2018
  • 58766:42 Use By: 06/20/2018

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 23 recalled by Guardian Pharmacy Services 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 23 products in this recall →

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