CVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr — Class II drug recall D-1306-2019
Terminated recall by Unipharma, Llc., reported 2019-05-22, distributed nationwide. CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bac
| Recall number | D-1306-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Unipharma, Llc., Tamarac, FL, United States |
| Recall initiated | 2019-05-02 |
| Classified | 2019-05-23 |
| Reported by FDA | 2019-05-22 |
| Terminated | 2020-11-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | VE |
| Quantity | 21,456 cartons |
| Reason classes | microbial contamination, cgmp |
| Pathogens | burkholderia |
| UPC / GTIN / UDI-DI | 00050428598368 |
| NDC | 69842-0262-01 |
| Lot numbers | 80054, 80056 |
| Expiration dates | 2020-10-31 |
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
Reason for recall
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1306-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.