Pharmedium Recalls Succinylcholine Chloride Injection Due to Stability Data Concerns
Pharmedium Services, LLC is recalling 2,495 syringes of succinylcholine chloride injection because stability data does not support the expiration dates, posing a risk of loss of potency.
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 FDA classified this recall as Class II. According to the rubric, an FDA Class II recall with potential for significant adverse health consequences (loss of potency in a critical IV medication) corresponds to a severity score of 4 (Severe), as it does not meet the criteria for Class I (Critical) but exceeds the threshold for High due to the agency's specific classification.
Plain-English summary
Pharmedium Services, LLC is recalling 2,495 syringes of succinylcholine chloride injection, 20 mg per mL, 100 mg per 5 mL, 5 mL total volume in a syringe, for IV use. The product is identified by product code 2R3357 and specific lot numbers: 15112035M, 15112036M, 15113006M, 15113026M, and 15113078M, with expiration dates between 07/15/15 and 10/12/15.
The recall was initiated because stability data does not support the expiration dates for the drugs packaged and stored in syringes. This condition creates a potential for loss of potency in the medication. The affected product was distributed nationwide.
Healthcare providers and patients should stop using the affected lots of succinylcholine chloride injection and contact Pharmedium Services, LLC for further instructions or a replacement. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- succinylcholine Chloride Injection, 20 mg per mL, 100 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3357.
- Manufacturer
- Pharmedium Services, LLC
- Category
- Drug — Injectable
- Affected units
- 2,495
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 (6)
- Lot Numbers: 15112035M
- 15112036M
- 15113006M
- 15113026M
- 15113078M
- Exp between 07/15/15-10/12/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 69 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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