Drug product
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
D-1631-2019
Product summary
- Firm
- Unipharma, Llc.
- Event
- Event 83492
- Status
- Terminated
- Classification
- Class II
- Quantity
- 48 cartons
- Official record key
drug-enforcement:D-1631-2019
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: 80060 Exp. 11/30/20
Distribution pattern: Nationwide in the US.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations