Drug Recall Enforcement Report Class III voluntary initiated by American Health Packaging, originally initiated on 02-19-2019 for the product Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, Manufactured by: Lupin Limited, Goa 403 722 INDIA For BluePoint Laboratories. The product was recalled due to cgmp deviations: finished product made with lovastatin drug substance that was out of specification for individual impurity results.. The product was distributed nationwide and the recall is currently terminated.
| Field Name |
Field Value |
| Event ID |
83471 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number |
D-1584-2019 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification |
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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 USA and Puerto Rico 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 |
Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, Manufactured by: Lupin Limited, Goa 403 722 INDIA For BluePoint Laboratories. |
| Reason For Recall |
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results. What is the Reason for Recall?
Information describing how the product is defective. |
| Product Quantity |
14,360 bottles 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 |
08-14-2019 |
| Recall Initiation Date |
02-19-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. |
| Termination Date |
09-09-2020 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 |
American Health Packaging |
| Code Info |
Lot #: a) G702705 and b) G702706, Exp. 3/31/2020 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 |
68001-314-00; 68001-314-08; 68001-315-00; 68001-315-08; 68001-316-00; 68001-316-08 |
| 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. |
Recalled Products
