June 2020 FDA Recall Drug by Sca Pharmaceuticals
D-1311-2020 - Subpotent Drug
This Class II drug recall was voluntarily initiated by Sca Pharmaceuticals on June 16, 2020 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed in Product was distributed to hospitals in PA and CA. and the recall is currently terminated.
Recall Number: D-1311-2020
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
06-16-2020
06-24-2020
333 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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to hospitals in PA and CA.
03-17-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx Only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46
Batch or Lot Expiration Information
Lot# : 1220017764, exp. date June 24, 2020
