Pallimed Solutions Recalls Atropine Injection Due to Sterility Concerns
Pallimed Solutions is recalling Atropine Injection compounded in Woburn, MA, due to FDA inspectional findings regarding quality control and 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 classification is FDA Class II. According to the rubric, FDA Class II recalls are categorized as Severe (Score 4), particularly when involving sterility assurance failures which pose significant health risks.
Plain-English summary
Pallimed Solutions Pharmacy in Woburn, Massachusetts, is recalling Atropine Injection. The recall was initiated following FDA inspectional findings that raised concerns about quality control procedures impacting the assurance of sterility for the product.
The recall covers all lots of the Atropine Injection within their expiry dates. The distribution pattern for the affected product is nationwide.
Consumers and healthcare providers should stop using the recalled Atropine Injection and contact their pharmacist or healthcare provider for further instructions or a replacement.
The recalled product
- Product
- Atropine Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
- Manufacturer
- Pallimed Solutions
- Category
- Drug — Injection
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 within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 25 recalled by Pallimed Solutions 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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