A&H Focal Inc. Recall: Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in fo
A&H Focal Inc. Recall: Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in fo is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: A&H Focal Inc.; Product: Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language; Reason for recall: Marked Without An Ap
| Recalling firm | A&H Focal Inc. |
|---|---|
| Product | Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language |
| Reason for recall | Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Terminated |
| Distribution | NY and NJ through six retail stores named "Asian Food Markets" |
| Recall initiated | 20170307 |
| Recall number | D-0563-2018 |
| Category | drug |
| State | NY |
| Country | United States |
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