SCA Pharmaceuticals Recalls Atropine Sulfate Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling Atropine Sulfate Injection syringes 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in a medical injection, which poses a significant risk of infection or injury.
Plain-English summary
SCA Pharmaceuticals is recalling 1,930 syringes of Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe. The recall is due to 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 was distributed to hospitals nationwide. The specific lots involved are #1220023001 (Best Use Date 2/5/2021), #1220023126 (Best Use Date 2/9/2021), and #1220023606 (Best Use Date 2/25/2021).
Hospitals and healthcare facilities should check their inventory for these specific lot numbers and discontinue use of the affected syringes. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004004006
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 1,930
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 (5)
- Lot # 1220023001
- BUD 2/5/2021
- 1220023126
- BUD 2/9/2021 & 1220023606
- BUD 2/25/2021.
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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