FDAFDA · Food and drugs·Recall number D-1631-2019
CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution, Antihistamine, Mixed Berry Flavor, 20 Single-Use Vials per Carton, 0.17 fl. oz. (5 mL) Each, 3.4 fl. oz. (100 mL) Total Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 69842-261-01 UPC 050428597156
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: 80060 Exp. 11/30/20
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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