NEOGEN-D — Class II drug recall D-1506-2019
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-1506-2019 |
|---|---|
| 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 | 2,052 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 52083-0699-16 |
Product
NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7.5 mg) in each 5 mL tsp, Raspberry Flavor, 16 fl oz (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-699-16.
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-1506-2019. 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.