Drug product
CVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg Cough Suppressant Guaifenesin, USP 100 mg Expectorant Mixed Berry Flavor 20 Single-Use Vials 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895,NDC 69842-262-01, UPC 050428598368
D-1306-2019
Product summary
- Firm
- Unipharma, Llc.
- Event
- Event 82754
- Status
- Terminated
- Classification
- Class II
- Quantity
- 21456 cartons
- Official record key
drug-enforcement:D-1306-2019
Official wording
Reason: CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Code information: Lots: 80054; 80056 Exp. 10/31/20
Distribution pattern: Nationwide and Venezuela
Derived failure modes
-
Manufacturing or process control
CGMP Deviations