SCA Pharmaceuticals, LLC. recalls labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095…

Recall date

February 22, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0603-2018

FDA classification

Class III

Brand / firm

SCA Pharmaceuticals, LLC.

Sold / distributed

GA, NE & PA

Why it was recalled

Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC 70004070028