Drug recall D-1212-2018
Product
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.
Lots and codes
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
Recall details
- Recalling firm
- InvaGen Pharmaceuticals, Inc., Hauppauge, NY
- Quantity
- 26,496 bottles
- Distribution
- Product was distributed to 14 major distributors who shipped the product U.S.A. nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 6, 2018
- Terminated
- October 22, 2020
Related products
- Bupropion hydrochloride – drug information
- NDC 69097-875 Bupropion Hydrochloride (XL) · Bupropion Hydrochloride 150 mg/1 · CIPLA USA INC.,
- NDC 69097-876 Bupropion Hydrochloride (XL) · Bupropion Hydrochloride 300 mg/1 · CIPLA USA INC.,