Drug Recall Enforcement Report Class II voluntary initiated by Sun Pharma Global Fze, originally initiated on 02-11-2016 for the product Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 41616-638-68, UPC 3 41616 63868 4. The product was recalled due to failed impurities/degradation specifications: observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.. The product was distributed nationwide and the recall is currently terminated.
| Field Name |
Field Value |
| Event ID |
73420 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number |
D-0735-2016 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 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 |
Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 41616-638-68, UPC 3 41616 63868 4. |
| Reason For Recall |
Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point. What is the Reason for Recall?
Information describing how the product is defective. |
| Product Quantity |
381,120 cartons 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 |
03-09-2016 |
| Recall Initiation Date |
02-11-2016 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. |
| Termination Date |
05-23-2017 What is the Date Terminated?
The date that FDA terminated the recall. |
| Initial Firm Notification |
E-Mail 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 |
Sun Pharma Global Fze |
| Code Info |
Lot #s: JKP2234A, JKP2235A, Exp 04/17 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. |
| 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. |
