FDAFDA · Food and drugs·Recall number D-1135-2017
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.
Published September 20, 2017 · Recall initiated: August 30, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Mid Valley Pharmaceutical
- Distributor
- TX
- Lot
- Lot: 23221701, Exp. 05/19
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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