Agency classClass IIOur severity:Severe FDA (Drugs)·D-0206-2021·Announced 2021-01-13

SCA Pharmaceuticals Recalls Rocuronium Syringes Due to Sterility Concerns

SCA Pharmaceuticals is recalling 7,940 syringes of Rocuronium Br 100 mg/10mL because defective caps may compromise sterility. The product was distributed to hospitals nationwide.

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 classified this as an FDA Class II recall. According to the rubric, FDA Class II recalls involving potential sterility issues in injectable medications are categorized as Severe (Score 4) due to the risk of infection or serious injury, even if specific hospitalization reports are not detailed in the provided text snippet.

Plain-English summary

SCA Pharmaceuticals is voluntarily recalling 7,940 syringes of Rocuronium Br 100 mg/10mL (10 mg/mL), a prescription-only medication. The recall is due to a lack of assurance of sterility, caused by a potential defect in the syringe cap that may result in a non-integral unit.

The affected product was distributed to hospitals nationwide. Specific lot numbers and expiration dates are listed in the official recall notice, including lots with best-use dates ranging from January 21, 2021, to February 11, 2021.

Hospitals and healthcare facilities should stop using the affected syringes and contact SCA Pharmaceuticals for instructions on how to return or dispose of the product. Patients who have received this medication should consult their healthcare provider if they have concerns.

The recalled product

Product: Rocuronium Br 100 mg/10mL (10 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR, 72205, barcode 70004085012
Manufacturer: SCA Pharmaceuticals
Category: Drug — Injectable Medication
Hazard: sterility
infection-risk
Affected units: 7,940

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 (17)

Lot # 1220022998
BUD 1/21/2021
1220023115
BUD 1/25/2021
1220023163
BUD 1/26/2021
1220023186
BUD 1/27/2021
1220023234
BUD 1/31/2021
1220023393
BUD 2/3/2021
1220023477
BUD 2/4/2021
1220023568
BUD 2/9/2021 & 1220023625
BUD 2/11/2021.

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