Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per…

Is this the product you have?

• Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172
• NDC69374-957-10

Lot codes and dates

11 of 11 products

Products covered by this recall

#	Product as published
1	PE2004A, Exp. 7/11/2022
2	PE2008A, Exp. 7/22/2022
3	PE2008B, Exp. 7/22/2022
4	PE2008C, Exp. 7/22/2022
5	PE2009A, Exp. 8/5/2022
6	PE2009B, Exp. 8/5/2022
7	PE2009C, Exp. 8/5/2022
8	PE2011B, Exp. 8/22/2022
9	PE2017C, Exp. 9/14/2022
10	PE2019B, Exp. 4/11/2023
11	PE2019C, Exp. 4/11/2023

Amount recalled

464,265 syringes

This recall covers 37 products

The agency filed one notice per product. You are reading one of them; the other 36 are below.

• Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outsourcing…
• Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe, packaged in 5 x 3 mL…
• 0.125% Bupivacaine HCl Injection, USP, 62.5 mg/50 mL (1.25 mg/mL) syringes, packaged in…
• 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL (9 mg/mL)…
• Bupivacaine HCl 150 mg (3.0 mg/mL), Ketorolac Tromethamine 60 mg (1.2 mg/mL), Ketamine…
• EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL) syringes, 5 x 10 mL Pre-Filled…
• EPINEPHrine Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL…
• 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) syringes, packaged in 5 x 5 mL…
• Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL) syringes, packaged in 5 x 3 mL…
• HYDROmorphone HCl Injection, USP, 10 mg/50 mL (0.2 mg/mL) syringes, 5 x 50 mL…
• HYDROmorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL) syringes, 5 x 30 mL Pre-Filled…

24 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.