April 2015 FDA Recall Drug by Sca Pharmaceuticals
D-1133-2015 - Labeling
This Class II drug recall was voluntarily initiated by Sca Pharmaceuticals on April 28, 2015 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in CA and the recall is currently terminated.
Recall Number: D-1133-2015
Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather than phenylephrine 50 mg in 5% dextrose.
04-28-2015
06-17-2015
50 bags
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
SCA Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
CA
12-09-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag (Concentration = 0.2 mg per mL), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR (877) 550-5059, barcode 88888772029.
Batch or Lot Expiration Information
Lot# Lot: 20150423@47, Exp 07/22/15
