Pharmakon Recalls Succinylcholine Syringes Due to Stability Data Concerns
Pharmakon Pharmaceuticals is recalling 2,750 syringes of Succinylcholine 20 mg/mL because stability data does not support the expiration dates.
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 agency classification is FDA Class II, which corresponds to a severity score of 4 (Severe) according to the rubric.
Plain-English summary
Pharmakon Pharmaceuticals is recalling 2,750 syringes of Succinylcholine 20 mg/mL, injectable, packed in syringes with a total dosage of 100 mg/5 mL. The product is prescription-only. The recall covers 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. The agency has classified this recall as Class II.
The product was distributed nationwide. Consumers and healthcare providers should stop using the affected product and contact Pharmakon Pharmaceuticals for further instructions.
The recalled product
- Product
- Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.
- Manufacturer
- Pharmakon Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
- Affected units
- 2,750
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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