Pharmakon Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns
Pharmakon Pharmaceuticals is recalling 2,175 units of Succinylcholine Chloride 20 mg/mL syringes due to a lack of assurance of sterility.
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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of infection associated with non-sterile medical devices.
Plain-English summary
Pharmakon Pharmaceuticals, Inc. is recalling 2,175 units of Succinylcholine Chloride 20 mg/mL, 10 mL BD syringes (NDC 45183-0920-72). The recall is being conducted because of a lack of assurance of sterility for the compounded sterile products.
The affected products were distributed nationwide, including to VA and DOD facilities in California, Kentucky, Maryland, North Carolina, Oklahoma, Texas, and Virginia. The recall covers all sterile compounded products within their expiry dates.
Consumers and healthcare providers should stop using the affected syringes and contact Pharmakon Pharmaceuticals for further instructions or a return.
The recalled product
- Product
- Succinylcholine Chloride 20 mg/mL, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0920-72
- Manufacturer
- Pharmakon Pharmaceuticals, Inc.
- Hazard
- Affected units
- 2,175
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 Sterile Compounded Products within Expiry
Distribution
Part of a larger recall action
This product is one of 88 recalled by Pharmakon Pharmaceuticals, Inc. 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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