Recall Enforment Report D-1212-2018

Drug Recall Enforcement Report Class III voluntary initiated by InvaGen Pharmaceuticals, Inc., originally initiated on 09-06-2018 for the product Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-count bottle (NDC 68001-322-05), For BluePoint Laboratories, Rx only, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 The product was recalled due to failed impurities/ degradation specifications: out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.. The product was distributed nationwide and the recall is currently terminated.

Field Name	Field Value
Event ID	80973 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1212-2018 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	Product was distributed to 14 major distributors who shipped the product U.S.A. nationwide. 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	Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-count bottle (NDC 68001-322-05), For BluePoint Laboratories, Rx only, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788
Reason For Recall	Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	26,496 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	09-26-2018
Recall Initiation Date	09-06-2018 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	10-22-2020 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	InvaGen Pharmaceuticals, Inc.
Code Info	Lot #: a) 1612130, 1612131, Exp 11/18; 1709986, Exp 8/19; 1711549, Exp 10/19; b) 1701171, 1701174, 1701175, 1701176, Exp 12/18; 1705131, 1705132, 1705133, Exp 4/19; 1709986, 1709985, Exp 8/19; 17110257, Exp 9/19; 1712809, 1801041, 1801051, Exp 12/19; 1802283, Exp 1/20 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	69097-875-02; 69097-875-05; 69097-875-12; 69097-876-02; 69097-876-12; 68001-322-05
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