The Recall Registry
Recall data checked 7 hours ago

Home Prescription medicine SCA Pharmaceuticals, LLC — PHENYLephrine HCl…

Food & drug recall · FDANovember 9, 2023Serious

SCA Pharmaceuticals, LLC — 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 70004-0810-12, Bar C

Do not stop taking this without speaking to your pharmacist or doctor.

What’s wrong

Lack of Assurance of Sterility

The Recall Registry rates this seriousFDA Class II: temporary or medically reversible health harm.

What to do

Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.

Who to contact: Recalling firm: SCA Pharmaceuticals, LLC

The product

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 70004-0810-12, Bar Code 70004081012

Details

Units affected
33,072 syringes; expanded 9,041 syringes
Recall date
November 9, 2023
Brand
SCA Pharmaceuticals, LLC
Model, lot or SKU numbers
Lot #: 1223045536 Exp 12/06/231223045710 Exp 12/10/231223046574 Exp 01/12/241223047579 Exp 02/21/241223047764 Exp 03/06/241223048363 Exp 03/30/241223048364 Exp 03/30/241223048566 Exp 04/06/241223048573 Exp 04/07/241223048574 Exp 04/07/241223048643 Exp 04/11/241223048697 Exp 04/12/241223048742 Exp 04/13/24 Expanded lots#: 1223048065, Exp 04/06/20241223048395, 1223048397, Exp 03/27/20241223049980, Exp 06/05/2024
Where it was distributed

Nationwide in the USA

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: SCA Pharmaceuticals, LLC — 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 70004-0810-12, Bar C

Read it on FDA

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Prescription medicine

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