Reported Jan 13, 2021 · Terminated
Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, 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?
- Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043009
- Lot codes and dates
Lot # 1220023040BUD 1/19/20211220023070BUD 1/21/20211220023105BUD 1/25/20211220023158BUD 1/26/20211220023315BUD 2/1/20211220023342BUD 2/2/20211220023431BUD 2/4/20211220023471BUD 2/3/20211220023481BUD 2/4/2021 & 1220023509BUD 2/8/2021
- Amount recalled
- 9942 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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