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 Pharm
Check against the official notice below — it lists the full affected range.
InvaGen Pharmaceuticals, Inc. is recalling Bupropion Hydrochloride ER Tablets, USP 150 mg in 90-count bottles manufactured for Cipla USA Inc. The recall affects approximately 26,496 bottles that were distributed nationwide to 14 major distributors. The product is being recalled because batches that are 18 months or older from their date of manufacture showed out-of-specification results for meta-chlorobenzoic acid impurity, which is a degradation product that exceeded acceptable limits.
The affected lot numbers and expiration dates are: 1612130 and 1612131 (Exp 11/18), 1709986 (Exp 8/19), 1711549 (Exp 10/19), 1701171, 1701174, 1701175, and 1701176 (Exp 12/18), 1705131, 1705132, and 1705133 (Exp 4/19), 1709985 (Exp 8/19), 17110257 (Exp 9/19), 1712809, 1801041, and 1801051 (Exp 12/19), and 1802283 (Exp 1/20). The recall notice does not specify what action affected consumers should take regarding their use of this medication.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: Product was distributed to 14 major distributors who shipped the product U.S.A. nationwide. Quantity: 26,496 bottles Lot/code info: 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
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.