# FDA recall D-1135-2017

> **Mid Valley Pharmaceutical** · Class II · drug recall initiated 2017-08-30.

## Product

Doctor Manzanilla Allergy & Decongestant Relief  (diphenhydramine hydrochloride and phenylephrine hydrochloride) Syrup, 12.5 mg and 5 mg in each 5 mL, 4 fl oz. (118 mL) bottle, Distributed by: Midvalley Pharmaceuticals, Raymondville, TX  78580, UPC 7 62558 00204 1.

## Reason for recall

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

## Distribution

TX

## Key facts

- **Recall number:** D-1135-2017
- **Recalling firm:** Mid Valley Pharmaceutical
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-08-30
- **Report date:** 2017-09-20
- **Termination date:** 2020-05-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Raymondville, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1135-2017

## Citation

> AI Analytics. FDA recall D-1135-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1135-2017. Source: US FDA. Licensed CC0.

---

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