Drug 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

D-0619-2018

March 15, 2018

Class III

Product summary

Firm: InvaGen Pharmaceuticals, Inc.
Event: Event 79446
Status: Terminated
Classification: Class III
Quantity: N/A
Official record key: drug-enforcement:D-0619-2018

Official wording

Reason: Failed Dissolution Specifications; during stability testing

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

Distribution pattern: Nationwide

Derived failure modes

Potency or specification failure
reason.potency_specification_failure · v1.0.0

Failed Dissolution Specifications