The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0418-2016·Announced 2015-12-09

Western Drug Recalls Ascorbic Acid Injection Due to Sterility Concerns

Western Drug is recalling Ascorbic Acid 500 mg/mL Injection because the product lacks assurance of sterility. The recall covers six containers distributed nationwide.

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, which indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. Lack of sterility in an injectable drug is a significant risk that fits the 'Severe' criteria for Class II recalls with potential for serious harm.

Plain-English summary

Western Drug Inc. is recalling six containers of Ascorbic Acid 500 mg/mL Injection, a prescription medication. The recall was initiated because the product lacks assurance of sterility, which is a critical quality attribute for injectable drugs.

The affected product was distributed nationwide in the United States, specifically in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah. The recall covers all lots of the product.

Healthcare providers and patients should stop using the recalled product and contact Western Drug Inc. or their local FDA office for further instructions on how to return or dispose of the medication.

The recalled product

Product
Ascorbic Acid 500 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Manufacturer
Western Drug
Category
Drug — Injectable
Hazard
Affected units
6

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 (1)

  • all lots

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 91 recalled by Western Drug 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 91 products in this recall →

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