March 2020 FDA Recall Drug by Nostrum Laboratories Inc
D-1059-2020 - CGMP Deviations

This Class II drug recall was voluntarily initiated by Nostrum Laboratories Inc on March 6, 2020 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in TN, MO and the recall is currently terminated.

Recall Number: D-1059-2020

Reason for Recall
CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/or Exp Date, product incorrectly labeled with incorrect lot and expiration date.
Initiated
03-06-2020
Reported
04-01-2020
Quantity
4722 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85235
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.
Nostrum Laboratories 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
TN, MO
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-01-2022
Product Description About Product Description
Full technical description of the product.
Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC 29033-001-01.

Batch or Lot Expiration Information

Lot# Lot: THE190501, Exp 11/2022