FDAFDA · Food and drugs·Recall number D-1632-2019
DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, Mixed berry Flavor, 20 Pre-measured Single-Use vials per Carton, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, UPC 370302255010
Published August 14, 2019 · Recall initiated: July 15, 2019
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 as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Unipharma, Llc.
- Distributor
- Nationwide in the US.
- Lot
- Lot: 90003 Exp. 01/31/21
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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