SCA Pharmaceuticals Recalls Neostigmine Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 390 syringes of neostigmine methylsulfate 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 FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential sterility issues in injectable products.
Plain-English summary
SCA Pharmaceuticals is recalling 390 single-dose syringes of neostigmine methylsulfate 5 mg/5 mL (1mg/ml). The product is identified by Lot # 1220023044 and has a beyond-use date of 1/30/2021. The recall was initiated 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. This is a prescription-only medication. The FDA 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, or where the probability of serious adverse health consequences is remote.
Healthcare facilities should stop using the affected product and contact SCA Pharmaceuticals for further instructions. Consumers should not use the product and should contact their healthcare provider if they have questions.
The recalled product
- Product
- neostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004075009
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
- Affected units
- 390
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 # 1220023044
- BUD 1/30/2021
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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