# FDA recall D-1345-2015

> **Sun Pharma Global Fze** · Class III · drug recall initiated 2015-07-17.

## Product

buPROPion Hydrochloride Extended-¿release Tablets USP  (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, Manufactured By: Sun Pharmaceutical Ind. Ltd., Halol Baroda Highway, Halol 389 350, Gujarat, India, NDC 47335-738-86

## Reason for recall

Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1345-2015
- **Recalling firm:** Sun Pharma Global Fze
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-07-17
- **Report date:** 2015-08-26
- **Termination date:** 2016-03-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sharm, United Arab Emirates

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1345-2015

## Citation

> AI Analytics. FDA recall D-1345-2015. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1345-2015. Source: US FDA. Licensed CC0.

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