The last Recall Enforcement Report for Acetaminophen with NDC 0904-6730 was initiated on 02-03-2020 as a Class II recall due to presence of foreign tablets/capsules: complaint involving one women's prenatal dietary supplement tablet commingled in a bottle of extra strength acetaminophen 500 mg contents 1000 count bottle. The latest recall number for this product is D-0858-2020 and the recall is currently ongoing .
Recall Number D-0858-2020
||84857 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
||D-0858-2020 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
||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 What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
||Nationwide within the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
||Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer, packaged in a) 100-count bottles (NDC 0904-6730-60; UPC 3 09046 73060 6) and b) 1000-count bottles (NDC 0904-6730-80; UPC 3 09046 73080 4) Distributed by Major Pharmaceuticals 17177 N. Laurel Park Drive, Suite 233 Livonia, MI 45162 USA
|Reason For Recall
||Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle. What is the Reason for Recall?
Information describing how the product is defective.
||a) 1176 bottles b) 6,216 bottles Product Quantity
The amount of product subject to recall.
||Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
|Recall Initiation Date
||02-03-2020 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
|Initial Firm Notification
||Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
||Contract Pharmacal Corporation
||Lot #: 193005, Exp. Date 08/21 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
|Recalled NDC Packages
||0904-6730-60; 0904-6730-80; 0904-6730-59; 0904-6730-61
||View Recall Report
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.