Pharmakon Recalls Glycopyrrolate Syringes Due to Stability Data Concerns
Pharmakon Pharmaceuticals is recalling 1,530 syringes of Glycopyrrolate 0.2 mg/mL because stability data does not support the expiration dates.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to stability data concerns regarding expiration dates, which fits the rubric for moderate severity involving potential but not immediate serious harm.
Plain-English summary
Pharmakon Pharmaceuticals is recalling 1,530 syringes of Glycopyrrolate 0.2 mg/mL, injectable, packed in syringes with a total dosage of 1 mg/5 mL. The product is prescription-only and was distributed nationwide. The recall affects all lots with expiration dates up to 11/17/2015.
The recall was initiated because stability data does not support the expiration dates for the product. This is an FDA Class II recall, which indicates 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.
Healthcare providers and patients should stop using the affected product and contact Pharmakon Pharmaceuticals for further instructions or a refund. Consumers should not use the recalled syringes.
The recalled product
- Product
- Glycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Manufacturer
- Pharmakon Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
- Affected units
- 1,530
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 with expiration dates up to 11/17/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Pharmakon Pharmaceuticals 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 22 products in this recall →Related recalls
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