PharMEDium Recalls Succinylcholine Chloride Syringes Due to Sterility Assurance Issues
PharMEDium Services is recalling 46 lots of succinylcholine chloride syringes because of a lack of sterility assurance. The products were distributed nationwide in the US.
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 with potential for adverse health consequences (such as lack of sterility assurance in IV products) are classified as Severe (Score 4), particularly when no specific hospitalization reports are cited to lower the score to High, but the defect is structural/quality-based rather than minor labeling.
Plain-English summary
PharMEDium Services, LLC is recalling 46 lots of succinylcholine chloride, 20 mg per 5 mL and 100 mg per 5 mL, 5 mL BD Syringes for IV use. The recall was initiated because of a lack of sterility assurance for these products.
The affected products, identified by NDC 71019-341-04, were distributed nationwide in the US. The specific lot codes associated with the recall are 193500014D (dated 3/16/2020) and 193510018D (dated 3/17/2020).
Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the affected products. 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, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, For IV Use, PharMEDium 913 N. Davis Ave, Cleveland, MS. NDC 71019-341-04
- Manufacturer
- PharMEDium Services, LLC
- Category
- Drug — Injectable Medication
- Affected units
- 2,475
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)
- 193500014D 3/16/2020 193510018D 3/17/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 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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