D-1212-2018 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 26, 2018
- Initiation Date
- September 6, 2018
- Termination Date
- October 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26,496 bottles
Product Description
Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-count bottle (NDC 68001-322-05), For BluePoint Laboratories, Rx only, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788
Reason for Recall
Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.
Distribution Pattern
Product was distributed to 14 major distributors who shipped the product U.S.A. nationwide.
Code Information
Lot #: a) 1612130, 1612131, Exp 11/18; 1709986, Exp 8/19; 1711549, Exp 10/19; b) 1701171, 1701174, 1701175, 1701176, Exp 12/18; 1705131, 1705132, 1705133, Exp 4/19; 1709986, 1709985, Exp 8/19; 17110257, Exp 9/19; 1712809, 1801041, 1801051, Exp 12/19; 1802283, Exp 1/20