# FDA recall D-0572-2016

> **Mutual Pharmaceutical Company,  Inc.** · Class II · drug recall initiated 2015-10-09.

## Product

Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count bottle, Rx only, Mfg. by: Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-0146-01

## Reason for recall

Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.

## Distribution

MS

## Key facts

- **Recall number:** D-0572-2016
- **Recalling firm:** Mutual Pharmaceutical Company,  Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-10-09
- **Report date:** 2016-01-27
- **Termination date:** 2016-10-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Philadelphia, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0572-2016

## Citation

> AI Analytics. FDA recall D-0572-2016. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0572-2016. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*