SCA Pharmaceuticals Recalls Rocuronium Bromide Syringes Due to Sterility Concerns
SCA Pharmaceuticals is recalling 487 syringes of Rocuronium Bromide 10 mg/mL due to a lack of assurance of sterility. The product was distributed 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric for drug recalls involving potential health risks.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling 487 syringes of Rocuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe (50 mg / 5 mL Total Dose). The recall is being conducted because of a lack of assurance of sterility for the product.
The affected product is identified by Lot 20171004@4 with a Beyond Use Date of 01/09/2018. The NDC number is 70004-850-09. The product was distributed nationwide in the United States.
This is a prescription-only medication. Healthcare providers and patients should stop using the affected syringes and contact SCA Pharmaceuticals for further instructions or a replacement.
The recalled product
- Product
- ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-850-09
- Manufacturer
- SCA Pharmaceuticals, LLC
- Category
- Drug — Injectable Medication
- Affected units
- 487
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 (1)
- Lot: 20171004@4 BUD: 01/09/2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by SCA Pharmaceuticals, LLC 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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