SCA Pharmaceuticals Recalls Sodium Citrate Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 5,990 syringes of Sodium Citrate 4% Anticoagulation Solution due to a lack of assurance of sterility and potential defective caps.
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 due to the potential for serious health consequences from non-sterile medical devices.
Plain-English summary
SCA Pharmaceuticals is recalling 5,990 syringes of Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL). 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 recall includes specific lots with expiration dates ranging from January 20, 2021, to February 23, 2021. The product is prescription-only and is packaged in 3 mL single-dose syringes.
Hospitals and healthcare facilities should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090025
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Anticoagulant Solution
- Affected units
- 5,990
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 (9)
- Lot # 1220022961
- BUD 1/20/2021
- 1220023121
- BUD 1/25/2021
- 1220023207
- BUD 2/12/2021
- 1220023363
- BUD 2/17/2021 & 1220023526
- BUD 2/23/2021.
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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