The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1159-2018·Announced 2018-09-05

Auro Pharmacies Recalls Glutathione Injectable Due to Sterility Concerns

Auro Pharmacies is recalling 183 vials of Glutathione injectable because inadequate processes and equipment were used to assure the sterility of the product.

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 and involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious health consequences such as infection.

Plain-English summary

Auro Pharmacies, Inc. is recalling 183 vials of Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial. The product was manufactured by Central Drugs Compounding Pharmacy and distributed nationwide in the USA. The specific lot number is 180716/21, with an expiration date of 14-Oct-18.

The recall was initiated due to a lack of assurance of sterility. The source text indicates that inadequate processes and equipment were used to assure the sterility of products intended to be sterile. This classification is designated as FDA Class II.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Glutathione injectable, 200 mg/mL, 30 mL Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
Manufacturer
Auro Pharmacies, Inc.
Category
Drug — Injectable
Hazard
Affected units
183

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 (2)

  • Lot #: 180716/21
  • Exp 14-Oct-18

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 12 recalled by Auro Pharmacies, Inc. 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 12 products in this recall →

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