Reported Jan 13, 2021 · Terminated
PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, 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?
- PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081022
- Lot codes and dates
Lot # 1220023003BUD 12/22/20201220023057BUD 12/25/20201220023104BUD 12/25/20201220023144BUD 12/27/20201220023168BUD 12/27/20201220023222BUD 12/29/20201220023240BUD 12/28/20201220023284BUD 1/1/20211220023456BUD 1/8/20211220023474BUD 1/4/20211220023530BUD 1/8/2021 & 1220023542BUD 1/9/2021
- Amount recalled
- 3152 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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