Agency classClass IIOur severity:Severe FDA (Drugs)·D-0198-2021·Announced 2021-01-13

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.

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, 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: sterility
defective-cap
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.

See all 32 products in this recall →

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Same hazard · sterility