InvaGen Pharmaceuticals, Inc. recalls Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Ci…

Recall date

September 6, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1212-2018

FDA classification

Class III

Brand / firm

InvaGen Pharmaceuticals, Inc.

Sold / distributed

Product was distributed to 14 major distributors who shipped the product U.S.A. nationwide.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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