Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled Syringes, 5 x 10 mL Pre-Filled Syringes, 6…

Is this the product you have?

• • Phenylephrine HCl Injection
  • USP
  • 0.8 mg/10 mL (80 mcg/mL)
  • 10 mL Pre-Filled Syringes
  • 5 x 10 mL Pre-Filled Syringes
  • 6 x 5 Syringe Carton
  • Rx Only
  • Nephron 503B outsourcing facility
  • 4500 12th St. Extension
  • West Columbia
  • SC 29172
• NDC69374-956-10

Lot codes and dates

• Lots
  • PE1107A
  • Exp. 5/22/2022
  • PE1123A
  • Exp. 6/21/2022
  • PE2007A
  • Exp. 8/4/2022
  • PE2012A
  • Exp. 8/28/2022

Amount recalled

76860 syringes

This recall covers 20 products

The agency filed one notice per product. You are reading one of them; the other 19 are below.

• 8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x 50 mL…
• Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL), 10 mL…
• EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10…
• Epinephrine Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10…
• Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 mcg/mL)…
• Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL), Preservative Free, 5 mL…
• Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL), Preservative Free, 3 mL…
• Hydromorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL), 50 mL Pre-Filled Syringe, 5 x…
• Hydromorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL), 30 mL Pre-Filled Syringe, 5 x…
• Ketamine Hydrochloride Injection, USP, 30 mg/3 mL (10 mg/mL), 3 mL Pre-Filled Syringe…
• Ketamine Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Pre-Filled Syringe…
• Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled…

7 more are in the archive.

Where it was sold

• Nationwide

Why it was recalled

Lack of Assurance of Sterility

This product could cause temporary or reversible health problems — stop using it.