Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmac...

FDA Recall #D-0367-2022 — Class III — December 3, 2021

Recall #D-0367-2022 Date: December 3, 2021 Classification: Class III Status: Terminated

Product Description

Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 -- NDC 50383-965-30

Reason for Recall

Labeling: Missing Label

Recalling Firm

Akorn, Inc. — Lake Forest, IL

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

10,836 bottles

Distribution

Nationwide USA

Code Information

Lot: 375153 Exp. 10/31/2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated