Bupropion Hydrochloride (sr) Tablet, Extended Release
FDA Recall NDC 69097-877
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Bupropion Hydrochloride (sr) (NDC 69097-877). A significant event, classified as Class III, was initiated on Mar 15, 2018 by Cipla Usa Inc.,. The reported reason for this action was: "Failed Dissolution Specifications; during stability testing"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
March 2018 Class III Recall: Failed Dissolution Specifications; during stability testing
Recall Number
Class III Terminated
Failed Dissolution Specifications; during stability testing
Mar 15, 2018
Apr 11, 2018
N/A
Recall Profile & Regulatory Data
Event ID
79446
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
InvaGen Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 15, 2021
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
Batch or Lot Expiration Information
Lot# I1606579 and
Lot# I1606580 Exp: 05/2018
Lot# I1612114 and
Lot# I1612115 Exp: 11/2018
Affected Packages Involved in this Recall
69097-877-02Product
69097-877-03Product
69097-877-07Product
69097-877-12Product
69097-878-02Product
69097-878-03Product
69097-878-07Product
69097-878-12Product
69097-879-02Product
69097-879-03Product
69097-879-07Product
69097-879-12Product
March 2018 Class III Recall: Failed Dissolution Specifications; during stability testing
Recall Number
Class III Terminated
Failed Dissolution Specifications; during stability testing
Mar 15, 2018
Apr 11, 2018
N/A
Recall Profile & Regulatory Data
Event ID
79446
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
InvaGen Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 15, 2021
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
Batch or Lot Expiration Information
Lot# 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
Affected Packages Involved in this Recall
69097-877-02Product
69097-877-03Product
69097-877-07Product
69097-877-12Product
69097-878-02Product
69097-878-03Product
69097-878-07Product
69097-878-12Product
69097-879-02Product
69097-879-03Product
69097-879-07Product
69097-879-12Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
