DOUBLE TUSSIN DM — Class II drug recall D-1498-2019
Terminated recall by Pharma-Natural Inc., reported 2019-07-31, distributed nationwide. CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability st
| Recall number | D-1498-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pharma-Natural Inc., Miami Lakes, FL, United States |
| Recall initiated | 2019-06-21 |
| Classified | 2019-07-23 |
| Reported by FDA | 2019-07-31 |
| Terminated | 2021-10-27 |
| Distributed | Nationwide (US) |
| Quantity | 500 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 63708-0121-04 |
Product
DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120 mL) bottle, Distributed by: Pamby Dist., Miami, FL 33414, NDC 63708-121-04.
Reason for recall
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
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-1498-2019. 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.