The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0260-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Glutathione Vials Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 367 vials of compounded Glutathione 200 mg/mL nationwide because the products lack assurance of sterility.

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, and the rubric specifies that FDA Class II recalls with potential for adverse health consequences (such as lack of sterility in injectable products) are categorized as Severe.

Plain-English summary

Tri-Coast Pharmacy is voluntarily recalling 367 vials of compounded Glutathione 200 mg/mL (30 mL) due to a lack of assurance of sterility. The recall covers all sterile products compounded between May 17, 2016, and November 17, 2016. The affected products were distributed nationwide.

The recall includes specific lot codes with expiration dates: 06082016A (09/06/2016), 07052016C (10/03/2016), 08082016A (11/06/2016), 09132016D (12/12/2016), and 10262016A (01/24/2016). 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 products and contact Tri-Coast Pharmacy for further instructions or a refund. Patients should consult their healthcare provider if they have any concerns regarding the use of these compounded sterile products.

The recalled product

Product
Glutathione 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Product
Hazard
Affected units
367

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)

  • 07052016C (10/03/2016)
  • 08082016A (11/06/2016)
  • 09132016D (12/12/2016)
  • 10262016A (01/24/2016).

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 80 recalled by Tri-Coast 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 80 products in this recall →

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