Agency classClass IIOur severity:Severe FDA (Drugs)·D-0195-2015·Announced 2014-11-12

FDA Recalls Injectable Glutathione Due to Sterility Assurance Concerns

Oregon Compounding Centers is recalling injectable glutathione vials because quality control issues observed during an FDA inspection present a potential risk to 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving sterile injectable products where sterility assurance is compromised, representing a significant risk of harm.

Plain-English summary

Oregon Compounding Centers, Inc. dba Creative Compounds is recalling specific lots of GLUTATHIONE with preservative, 100mg/mL, injectable, 100 mL glass vials. The recall involves 2,200 mL of product distributed in Oregon and Washington.

The recall was initiated due to concerns associated with quality control procedures that present a potential risk to sterility assurance. These concerns were observed during a recent FDA inspection of the pharmacy. The affected lots are identified by Lot # 20140721@25/00 with a discard date of 11/18/2014, and Lot # 20140902@47 with a discard date of 12/31/2014.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. 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 with preservative, 100mg/mL, injectable, 100 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
Manufacturer: Oregon Compounding Centers, Inc. dba Creative Compounds
Category: Drug — Injectable Compounded Drug
Hazard: sterility-assurance
infection-risk

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 #: 20140721@25/00
discard date: 11/18/2014
Lot #: 20140902@47
discard date: 12/31/2014.

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 56 recalled by Oregon Compounding Centers, Inc. dba Creative Compounds 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 56 products in this recall →

Same manufacturer · Oregon Compounding Centers, Inc. dba Creative Compounds

See all →

Severe
Ganciclovir Syringes Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2014-11-12
Severe
FDA Recalls Papaverine Injectable Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-11-12
Severe
FDA Recalls Injectable Methycobalamin Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-11-12
Severe
Creative Compounds Recalls Ceftazidime Syringes Due to Sterility Concerns
FDA (Drugs) · 2014-11-12
Severe
FDA Recalls Vitamin B Complex Injectable Due to Sterility Concerns
FDA (Drugs) · 2014-11-12

Same hazard · sterility assurance