The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1056-2018·Announced 2018-08-15

Guardian Pharmacy Recalls Glutathione Vials Due to Sterility Concerns

Guardian Pharmacy Services is recalling 2,400 vials of compounded Glutathione 200 mg/mL 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 FDA classified this recall as Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility assurance) are categorized as Severe.

Plain-English summary

Guardian Pharmacy Services is recalling 2,400 vials of compounded Glutathione 200 mg/mL, packaged in 100 mL MDV vials. The product is prescription-only and was distributed in Texas. The recall is being conducted due to a lack of sterility assurance.

The affected lots include 58436:42 (Use By: 05/22/2018), 58653:42 (Use By: 06/12/2018), 58773:42 and 58766:42 (Use By: 06/21/2018), and 58766:42 (Use By: 06/20/2018). 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.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for further instructions.

The recalled product

Product
Glutathione 200 mg/mL 100ml. Rx Only. Packaged in 100 mL 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 (6)

  • Lots: 58436:42 Use By: 05/22/2018
  • 58653:42 Use By: 06/12/2018
  • 58773:42
  • 58766:42
  • 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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