Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language
Reported: February 7, 2018 Initiated: March 7, 2017 #D-0563-2018
Product Description
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.
Details
- Recalling Firm
- A&H Focal Inc.
- Units Affected
- unknown
- Distribution
- NY and NJ through six retail stores named "Asian Food Markets"
- Location
- Staten Island, NY
Frequently Asked Questions
What product was recalled? ▼
Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language. Recalled by A&H Focal Inc.. Units affected: unknown.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 7, 2018. Severity: Critical. Recall number: D-0563-2018.
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