# FDA recall D-1363-2019

> **Torrent Pharma Inc** · Class II · drug recall initiated 2019-05-21.

## Product

Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 16571-302-16, Distributed by Rising Pharmaceuticals Inc., Saddle Brook, NJ 07663

## Reason for recall

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

## Distribution

Product was distributed to 9 distributors, direct accounts and relabelers who may have further distributed the product throughout the United States.

## Key facts

- **Recall number:** D-1363-2019
- **Recalling firm:** Torrent Pharma Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-05-21
- **Report date:** 2019-06-19
- **Termination date:** 2020-10-06

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1363-2019

## Citation

> AI Analytics. FDA recall D-1363-2019. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-1363-2019. Source: US FDA. Licensed CC0.

---

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