Home / Recalls / InvaGen Pharmaceuticals, Inc. / D-0618-2018

D-0618-2018 Class III Terminated

Recalled by InvaGen Pharmaceuticals, Inc. — Hauppauge, NY

FDA drug recall D-0618-2018 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), 100 mg, 60 count 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 --- NDC 69097-877-03

Reason for Recall

Failed Dissolution Specifications; during stability testing

Distribution Pattern

Nationwide

Code Information

Lot# I1606579 and Lot# I1606580 Exp: 05/2018; Lot# I1612114 and Lot# I1612115 Exp: 11/2018

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0618-2018
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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