The last Recall Enforcement Report for Phentermine with NDC 13107-106 was initiated on 03-18-2020 as a Class II recall due to cgmp deviations: products were manufactured in a processing area in which water leakage was observed The latest recall number for this product is D-1236-2020 and the recall is currently terminated as of 03-25-2024 .
Recall Number D-1236-2020
Field Name |
Field Value |
Event ID |
85183 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
Recall Number |
D-1236-2020 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
Recall Classification |
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". |
Distribution Pattern |
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. |
Product Description |
Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01 |
Reason For Recall |
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed What is the Reason for Recall? Information describing how the product is defective. |
Product Quantity |
2101 units Product Quantity The amount of product subject to recall. |
Voluntary Mandated |
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. |
Report Date |
04-22-2020 |
Recall Initiation Date |
03-18-2020 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall. |
Termination Date |
03-25-2024 What is the Date Terminated? The date that FDA terminated 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. |
Product Type |
Drugs |
Recalling Firm |
Aurobindo Pharma USA Inc. |
Code Info |
Lot #: 105180004A, Exp. Date 03/2020 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 |
13107-105-30; 13107-105-01; 13107-106-30; 13107-106-01 |
Status |
Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard. |
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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.