SCA Pharmaceuticals Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 5,067 syringes of Succinylcholine Chloride 100 mg/5mL due to a lack of assurance of sterility and potential defective caps.
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 and involves a sterile injectable medication where a lack of sterility assurance poses a significant risk of infection or injury, meeting the criteria for a Severe rating.
Plain-English summary
SCA Pharmaceuticals is voluntarily recalling 5,067 syringes of SUCcinylcholine Chloride 100 mg/5mL, a prescription-only medication. The recall is being conducted because of a lack of assurance of sterility and the potential for a defective syringe cap, which could result in a non-integral unit.
The affected product is distributed to hospitals nationwide. The specific lots involved are 1220023019 (Best Use Date 1/17/2021), 1220023025 (Best Use Date 1/18/2021), 1220023026 (Best Use Date 1/24/2021), and 1220023264 (Best Use Date 2/1/2021). The product is identified by barcode 70004090809.
Hospitals and healthcare facilities should check their inventory for these specific lot numbers and discontinue use of the affected syringes. The U.S. Food and Drug Administration 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 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., WIndsor, CT, 06095, barcode 70004090809
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable Medication
- Affected units
- 5,067
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 (7)
- Lot # 1220023019
- BUD 1/17/2021
- 1220023025
- BUD 1/18/2021
- 1220023026
- BUD 1/24/2021 & 1220023264
- BUD 2/1/2021.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 32 recalled by SCA 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.
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