FDA Drug recall D-1301-2019
DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guaifenesin 100 mg Mixed Berry Flavor 20 Pre-measured Singe-Use 0.…
- FDA Drug
- Class II
- terminated
- Published 2019-05-22
On 2019-05-22 the FDA classified a Class II recall of DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guaifenesin 100 mg Mixed Berry Flavor 20 Pre-measured Singe-Use 0.… 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-1301-2019 |
| 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
DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guaifenesin 100 mg Mixed Berry Flavor 20 Pre-measured Singe-Use 0.17 fl. oz. (5 mL), Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-013-20, UPC 370302268010
Reason
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Identifiers
| upc | 370302268010 |
|---|---|
| code_info | Lot: 80054 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-1301-2019%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.