# FDA recall D-0618-2018

> **InvaGen Pharmaceuticals, Inc.** · Class III · drug recall initiated 2018-03-15.

## Product

buPROPion HCl Extended-Release Tablets,   USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 --- NDC 69097-877-03

## Reason for recall

Failed Dissolution Specifications; during stability testing

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0618-2018
- **Recalling firm:** InvaGen Pharmaceuticals, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-03-15
- **Report date:** 2018-04-11
- **Termination date:** 2021-09-15

- **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-0618-2018

## Citation

> AI Analytics. FDA recall D-0618-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0618-2018. Source: US FDA. Licensed CC0.

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