Home / Recalls / InvaGen Pharmaceuticals, Inc. / D-0619-2018

D-0619-2018 Class III Terminated

Recalled by InvaGen Pharmaceuticals, Inc. — Hauppauge, NY

FDA drug recall D-0619-2018 was initiated by InvaGen Pharmaceuticals, Inc. on Mar 15, 2018 and is designated Class III. Reason for recall: Failed Dissolution Specifications; during stability testing The recall status is terminated (terminated Sep 15, 2021).

Recall Details

Product Type: Drugs
Report Date: Apr 11, 2018
Initiation Date: Mar 15, 2018
Termination Date: Sep 15, 2021
Voluntary/Mandated: Voluntary: Firm initiated

Product Description

buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-878-07) bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788

Reason for Recall

Failed Dissolution Specifications; during stability testing

Distribution Pattern

Nationwide

Code Information

a) Lot I1606609 and Lot I1606610 Exp. Date 05/2018; Lot I1610639 Exp. Date 09/2018 b) Lot #I1606610 Exp Date 05/2018; Lot I1607847 and Lot I1607845 Exp Date 06/2018; Lot I1610639 Exp Date 09/2018

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0619-2018
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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