The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0638-2018·Announced 2018-04-25

Partell Specialty Pharmacy Recalls Glutathione Vials Due to Sterility Concerns

Partell Specialty Pharmacy is recalling four vials of Glutathione 200mg/mL in Nevada because the products were sterilized using a non-approved method.

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 source text explicitly identifies the agency classification as Class II. Per the rubric, if the agency's own classification is FDA Class II, the score must be at least 4 (Severe).

Plain-English summary

Partell Specialty Pharmacy is recalling four vials of Glutathione 200mg/mL, 10mL amber vials, prescription only. The recall is due to a lack of assurance of sterility, as the firm used a non-approved method of sterilization for these drug products.

The affected products are distributed only in Nevada. The specific lots involved are 20180219@58 (Best Use Date 05/20/2018), 20180131@15 (Best Use Date 05/01/2018), 20180116@9 (Best Use Date 04/14/2018), and 20180103@5 (Best Use Date 04/03/2018).

Consumers and healthcare providers should check their inventory for these specific lot numbers and discontinue use. The FDA has classified this as a Class II recall.

The recalled product

Product
Glutathione 200mg/mL, 10mL amber vial, Rx only, Partell Specialty Pharmacy, 5835 S. Eastern Ave. #101, Las Vegas, NV 89119 (702) 791-3800
Manufacturer
Partell Specialty Pharmacy
Category
Drug — 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 (8)

  • Lot#: 20180219@58
  • BUD 05/20/2018
  • 20180131@15
  • BUD 05/01/2018
  • 20180116@9
  • BUD 04/14/2018
  • 20180103@5
  • BUD 04/03/2018.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 49 recalled by Partell Specialty Pharmacy 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 49 products in this recall →

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