October 2020 FDA Recall Drug by Jarrow Formulas Inc (D-0302-2021 - Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap.)

This Class II drug recall was voluntarily initiated by Jarrow Formulas Inc on October 9, 2020 for the product Drug. The FDA reported the reason for recall as mislabeling of sus (n-a-c sustain 600 mg 100 tab) with n-a-c n-acetyl-l-cysteine 500 mg, 100 cap.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0302-2021

Reason for Recall
Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap.
Initiated
10-09-2020
Reported
11-04-2020
Quantity
533 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86617
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Jarrow Formulas Inc
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-09-2021
Product Description About Product Description
Full technical description of the product.
N-A-C (N-Acetyl-L-Cysteine, 500 mg, 100 capsules; Veggie Caps, white HDPE bottle with RED label Product # 107002 UPC: 790011070023

Batch or Lot Expiration Information

Lot# Lot 65323G20; Expiration: 7/22