# FDA recall D-1212-2018

> **InvaGen Pharmaceuticals, Inc.** · Class III · drug recall initiated 2018-09-06.

## 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.

## Distribution

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

## Key facts

- **Recall number:** D-1212-2018
- **Recalling firm:** InvaGen Pharmaceuticals, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-09-06
- **Report date:** 2018-09-26
- **Termination date:** 2020-10-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hauppauge, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1212-2018

## Citation

> AI Analytics. FDA recall D-1212-2018. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/D-1212-2018. Source: US FDA. Licensed CC0.

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