FDA Drug recall D-1297-2019
CVS Health Children's Mucus Relief Chest Congestion Plus Cough Dextromethorphan HBr Cough Suppressant Guaifenesin Expectorant Mixed Berry F…
- FDA Drug
- Class II
- terminated
- Published 2019-05-22
On 2019-05-22 the FDA classified a Class II recall of CVS Health Children's Mucus Relief Chest Congestion Plus Cough Dextromethorphan HBr Cough Suppressant Guaifenesin Expectorant Mixed Berry F… by Unipharma, citing CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1297-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-02 |
| Published | 2019-05-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Unipharma |
| Distribution | US |
Product
CVS Health Children's Mucus Relief Chest Congestion Plus Cough Dextromethorphan HBr Cough Suppressant Guaifenesin Expectorant Mixed Berry Flavor 20 Singe-Use Vials Per Carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-260-01, UPC 050428597675
Reason
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Identifiers
| upc | 050428597675 |
|---|---|
| code_info | Lots: 80053; 80055 Exp. 10/31/20 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1297-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.