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PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 ...

FDA Recall #D-0421-2024 — Class II — November 9, 2023

Recall #D-0421-2024 Date: November 9, 2023 Classification: Class II Status: Terminated

Product Description

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 70004-0816-12-K, Bar Code 700040081612. (same finished product as F078140, but with RFID for KitCheck compatibility)

Reason for Recall

Lack of Assurance of Sterility

Recalling Firm

SCA Pharmaceuticals, LLC — Windsor, CT

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

2,427 syringes

Distribution

Nationwide in the USA

Code Information

Lot #: 1223048610 Exp 04/10/24; 1223048611 Exp 04/10/24; 1223048726 Exp 04/13/24; 1223050163 Exp 06/12/24

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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