Drug product
CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL Pain reliever/Fever reducer Single-Use Vials Cherry Flavor 20 Single-Use Vials per carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-0258-01, UPC 050428601891
D-1296-2019
Product summary
- Firm
- Unipharma, Llc.
- Event
- Event 82754
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15264 cartons
- Official record key
drug-enforcement:D-1296-2019
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: 80061 Exp. 11/30/20
Distribution pattern: Nationwide and Venezuela
Derived failure modes
-
Manufacturing or process control
CGMP Deviations