Multi-event March 2018 FDA Recall Bupropion Hydrochloride
sr by Invagen Pharmaceuticals, Inc.
This Multi-event Class III drug recall was voluntarily initiated by Invagen Pharmaceuticals, Inc. on March 15, 2018 for the product Bupropion Hydrochloride (sr). The FDA reported the reason for recall as failed dissolution specifications; during stability testing. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0618-2018
Failed Dissolution Specifications; during stability testing
03-15-2018
04-11-2018
N/A
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
InvaGen Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
09-15-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-0619-2018
Failed Dissolution Specifications; during stability testing
03-15-2018
04-11-2018
N/A
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
InvaGen Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
09-15-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
