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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- 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
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.
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