The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0441-2016·Announced 2015-12-09

Western Drug Recalls Phenylephrine Injection Due to Sterility Concerns

Western Drug is recalling Phenylephrine 500mcg/mL Injection because the product lacks assurance of sterility. The recall covers all lots 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. The hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or death if contaminated, meeting the criteria for a Severe rating.

Plain-English summary

Western Drug Inc. is recalling Phenylephrine 500mcg/mL Injection, a prescription medication. The recall was initiated because the product lacks assurance of sterility. This means the manufacturer cannot guarantee that the injection is free from microbial contamination.

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

Healthcare providers and patients should stop using the recalled product. Consumers should contact their healthcare provider for guidance on alternative treatments or further instructions.

The recalled product

Product
Phenylephrine 500mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Manufacturer
Western Drug
Category
Drug — Injectable Medication
Hazard
Affected units
1

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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