SCA Pharmaceuticals Recalls Labetalol HCl Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 9,057 syringes of labetalol HCl injection due to a lack of assurance of sterility and potential defective syringe 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 severity score per the rubric, as it involves a potential health risk (lack of sterility) that could lead to serious adverse health consequences.
Plain-English summary
SCA Pharmaceuticals is voluntarily recalling 9,057 syringes of labetalol HCl 20 mg/4 mL Injection for Intravenous Use. The product is a prescription-only medication distributed to hospitals nationwide. 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 includes specific lots with expiration dates ranging from March 1, 2021, to March 22, 2021. The lot numbers are 1220022969, 1220023002, 1220023045, 1220023081, 1220023130, 1220023229, 1220023287, and 1220023335. The product is identified by the barcode 70004070028.
Hospitals and healthcare facilities should stop using the affected syringes and contact SCA Pharmaceuticals for further instructions. Patients who have received the medication should consult their healthcare provider if they have concerns.
The recalled product
- Product
- labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004070028
- Manufacturer
- SCA Pharmaceuticals
- Category
- Drug — Injection
- Hazard
- Affected units
- 9,057
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 (13)
- Lot # 1220022969
- BUD 3/1/2021
- 1220023002
- BUD 3/2/2021
- 1220023045
- 1220023081
- 1220023130
- BUD 3/6/2021
- 1220023229
- BUD 3/9/2021
- 1220023287
- BUD 3/12/2021 & 1220023335
- BUD 3/22/2021.
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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