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
Reported: August 14, 2019 Initiated: July 15, 2019 #D-1632-2019
Product Description
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
Reason for Recall
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Details
- Recalling Firm
- Unipharma, Llc.
- Units Affected
- 432 cartons
- Distribution
- Nationwide in the US.
- Location
- Tamarac, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Unipharma, Llc.. Units affected: 432 cartons.
Why was this product recalled? ▼
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 14, 2019. Severity: Moderate. Recall number: D-1632-2019.
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