US Compounding Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns
US Compounding Inc is recalling 1,590 syringes of Succinylcholine Chloride because deficient practices may have impacted sterility assurance.
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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for significant injury or property damage reports, or high-risk scenarios.
Plain-English summary
US Compounding Inc is recalling 1,590 syringes of Succinylcholine Chloride (200 mg/10 mL), 10 mL Single Use Syringe (20 mg/mL), For IV use, Rx only. The product was compounded by US Compounding Pharmacy in Conway, Arkansas, and distributed nationwide.
The recall was initiated due to a lack of assurance of sterility. The firm identified deficient practices that may have an impact on sterility assurance for all sterile preparations within expiry. The affected lot codes are 20152606@4 with a best use date of 9/23/2015, and 20151108@4 with a best use date of 11/9/2015.
Healthcare providers and consumers should stop using the affected product and contact the recalling firm for further instructions.
The recalled product
- Product
- Succinylcholine Chloride (200 mg/10 mL), 10 mL Single Use Syringe (20 mg/mL), For IV use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72653, NDC 62295-3292-07
- Manufacturer
- US Compounding Inc
- Category
- Drug — Injectable
- Affected units
- 1,590
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 (2)
- Lot Code: 20152606@4 BUD: 9/23/2015
- 20151108@49 BUD: 11/9/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by US Compounding 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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