FDA DrugsClass II
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Vanil...
Published: April 22, 2026Recall ID: D-0470-2026Category: drugsCountry: US
Reason for Recall / Hazard
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Product Description & Identification
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Vanilla Honey Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-620-30, UPC: 635515999411.
Additional Source Details
| Field | Value |
|---|---|
| City | Xiamen |
| State | N/A |
| Openfda › Upc | 635515999411 |
| Openfda › Unii | L7T10EIP3A |
| Openfda › Route | ORAL |
| Openfda › Rxcui | 616344 |
| Openfda › Spl id | 4718826f-cc59-8386-e063-6394a90a7ffb |
| Openfda › Brand name | QUALITY CHOICE COUGH DROPS VANILLA HONEY |
| Openfda › Spl set id | 23087ee3-26a0-e2b8-e063-6394a90abef4 |
| Openfda › Package ndc › 1 | 83698-620-30 |
| Openfda › Package ndc › 2 | 6355159994 |
| Openfda › Product ndc | 83698-620 |
| Openfda › Generic name | COUGH DROPS VANILLA HONEY |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name | MENTHOL, UNSPECIFIED FORM |
| Openfda › Manufacturer name | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. |
| Openfda › Application number | M012 |
| Openfda › Is original packager | true |
| Event id | 98648 |
| Address 1 | No. 2018 |
| Address 2 | 2 Jietou Road |
| Code info | Lot # 20240720, Exp Date: 07/20/2026. |
| Postal code | N/A |
| Report date | 20260422 |
| Product type | Drugs |
| Product quantity | N/A |
| Reason for recall | This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260320 |
| Initial firm notification | Letter |
| Center classification date | 20260410 |
Overview
- Recalling FirmXiamen Kang Zhongyuan Biotechnology Co., Ltd.
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide.