Reported Jan 13, 2021 · Terminated
Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(barcode 7000485009) Rx Only, SCA…
SCA Pharmaceuticals
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SCA Pharmaceuticals · 755 Rainbow Rd Ste B · Windsor, CT · 06095-1024
Is this the product you have?
- Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(barcode 7000485009) Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 and b) 5 mL Single Dose Syringe White Label (barcode 70004085028), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205
- Lot codes and dates
a) Lot # 1220023011BUD 1/12/20211220023027BUD 1/19/20211220023151BUD 1/26/20211220023152BUD 1/26/20211220023194BUD 1/26/20211220023228BUD 1/28/20211220023358. BUD 2/3/20211220023396. BUD 2/3/20211220023398BUD 2/10/20211220023569BUD 2/9/2021 & 1220023633BUD 2/11/2021. b)1220023031BUD 1/19/20211220023032BUD 1/24/20211220023161BUD 1/26/2021 & 1220023224BUD 1/28/2021
- Amount recalled
- 13,096 syringes
This recall covers 32 products
The agency filed one notice per product. You are reading one of them; the other 31 are below.
19 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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