Pharmedium Recalls Atropine Sulfate Injection Due to Sterility Concerns
Pharmedium Services, LLC is recalling all lots of Atropine Sulfate Injection nationwide due to a lack of sterility assurance.
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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe. While specific injury reports are not detailed in the text, the lack of sterility assurance in an injectable drug represents a significant health risk consistent with the Severe classification for Class II recalls.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling Atropine Sulfate Injection in all strengths, doses, and packaging. The recall is being conducted because of a lack of sterility assurance for the product.
The recall covers all lots of the medication that are remaining within their expiration dates. The product was distributed nationwide in the United States.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Atropine Sulfate Injection in all strengths, all doses, and all packaging.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable Medication
- Hazard
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 remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by Pharmedium Services, LLC 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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