Recalls / Class I
Class ID-0556-2018
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
GERMANY NIUBIAN tablets, 3000mg, 10-count bottle, labeling is in foreign language
- Affected lot / code info
- All Lots
Why it was 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.
Recalling firm
- Firm
- A&H Focal Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 119 Linwood Ave, Staten Island, New York 10305-4445
Distribution
- Quantity
- unknown
- Distribution pattern
- NY and NJ through six retail stores named "Asian Food Markets"
Timeline
- Recall initiated
- 2017-03-07
- FDA classified
- 2018-02-28
- Posted by FDA
- 2018-02-07
- Terminated
- 2019-06-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0556-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.