February 2018 FDA Recall Drug by Sca Pharmaceuticals, Llc.
D-0603-2018 - 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

This Class III drug recall was voluntarily initiated by Sca Pharmaceuticals, Llc. on February 22, 2018 for the product Drug. The FDA reported the reason for recall as 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. The product was distributed in GA, NE & PA and the recall is currently terminated.

Recall Number: D-0603-2018

Reason for Recall
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
Initiated
02-22-2018
Reported
03-14-2018
Quantity
480 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79265
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SCA Pharmaceuticals, LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
GA, NE & PA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-26-2019
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# lot 1217000213, exp 03/27/2019