Drug product
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
D-1632-2019
Product summary
- Firm
- Unipharma, Llc.
- Event
- Event 83492
- Status
- Terminated
- Classification
- Class II
- Quantity
- 432 cartons
- Official record key
drug-enforcement:D-1632-2019
Official wording
Reason: CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Code information: Lot: 90003 Exp. 01/31/21
Distribution pattern: Nationwide in the US.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations