PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022.

FDA recall notice · announced April 3, 2024 · Sca Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

Lack of Assurance of Sterility

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot #: 1223045282 Exp 11/24/23; 1223045370 Exp 11/26/23; 1223045624 Exp 12/07/23; 1223045723 Exp 12/10/23; 1223045732 Exp 12/10/23; 1223046128 Exp 12/24/23; 1223046133 Exp 12/24/23; 1223047112 Exp 02/02/24; 1223047232 Exp 2/07/24; 1223047398 Exp 02/15/24; 1223047456 Exp 02/16/24; 1223047569 Exp 02/18/24; 1223047694 Exp 02/24/24; 1223047780 Exp 03/07/24; 1223047859 Exp 03/08/24; 1223048119 Exp 03/20/24; 1223048183 Exp 03/22/24; 1223048837 Exp 04/18/24; 1223048838 Exp 04/18/24; 1223048982 Exp 04/24/24; 1223049144 Exp 05/02/24; 1223049145 Exp 05/02/24; 1223049147 Exp 05/02/24; 1223049821 Exp 05/30/24 Expanded Lot #: 1223048037, Exp 03/16/2024; 1223048047, Exp 03/17/2024; 1223049146, 1223049149, Exp 05/02/2024; 1223049373, Exp 05/10/2024; 1223048909, Exp 04/20/2024; 1223048696, Exp 04/12/2024; 1223050181, Exp 06/12/2024
Quantity: 5,948 syringes, expanded 2,102 syringes
Status: Terminated
Products in this recall event:
- labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028 (D-0411-2024)
- HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-21, Bar C (D-0410-2024)
- PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0825-40, Bar Code 700040 (D-0419-2024)
- fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rai (D-0399-2024)
- fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repackaged by SCA Pharma. SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, ND (D-0402-2024)
- HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar (D-0407-2024)
- PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-081 (D-0418-2024)
- SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-09, Bar Code 7000 (D-0424-2024)
- fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, 877.550.5059, NDC 70004-0229-40 B (D-0395-2024)
- fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0202-22, B (D-0403-2024)
- neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0750-09, Bar Code 70004075009 (D-0413-2024)
- HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-18, Bar Code 7000403001 (D-0406-2024)
- Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0900-25, Bar Code 700040 (D-0422-2024)
- fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceutical (D-0400-2024)
- PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816 (D-0421-2024)
- HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-63, Bar (D-0404-2024)
- PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816 (D-0420-2024)
- HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-17 (D-0408-2024)
- Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0411-59, Bar Code 700040 (D-0412-2024)
- Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095; NDC 70004-0541-35, Bar Code 70004054135 (D-0394-2024)
- fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceutic (D-0398-2024)
- PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0 (D-0414-2024)
- fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceutica (D-0401-2024)
- HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC (D-0405-2024)
- VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0923-59, Bar Code 70004092359 (D-0425-2024)
- HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70 (D-0409-2024)
- PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810 (D-0415-2024)
- SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-12, Bar Code 7 (D-0423-2024)
- PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810 (D-0416-2024)
- fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0222-30 BAR code 70004022230 (D-0396-2024)
- fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow R (D-0397-2024)
- PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar (D-0417-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.