Pharmedium Recalls Glycopyrrolate Due to Lack of Sterility Assurance
Pharmedium Services, LLC is recalling all strengths and packaging of Glycopyrrolate due to a lack of sterility assurance. The recall covers all lots remaining within their expiry dates 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 corresponds to a Severe severity score under the rubric for significant injury or risk of harm.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling Glycopyrrolate in all strengths, all doses, and all packaging. The recall is being conducted because of a lack of sterility assurance in the product.
The affected product includes all lots remaining within their expiry dates. The distribution pattern for this recall is nationwide across the United States.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions. No specific lot numbers are listed in the source text, so all remaining stock within the expiry date is considered affected.
The recalled product
- Product
- Glycopyrrolate in all strengths, all doses, and all packaging.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable Medication
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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