February 2018 FDA Recall Drug by Nostrum Laboratories Inc
D-0473-2018 - Presence of Foreign Tablets/Capsules

This Class III drug recall was voluntarily initiated by Nostrum Laboratories Inc on February 13, 2018 for the product Drug. The FDA reported the reason for recall as presence of foreign tablets/capsules. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0473-2018

Reason for Recall
Presence of Foreign Tablets/Capsules
Initiated
02-13-2018
Reported
02-28-2018
Quantity
1,439,000 oral capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79210
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-13-2018
Product Description About Product Description
Full technical description of the product.
Calcium Acetate Capsules, 667 mg, 200 Capsules per bottle, Rx Only. Manufactured by Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-026-02

Batch or Lot Expiration Information

Lot# Lot: CAL173502; Exp. 09/19