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.
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 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
- 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.
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