Recalls / Class I
Class ID-1597-2014
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
Black Ant, 4600 mg, four capsules per box, , Manufacturer Timpo Bioengineering Co., Ltd, USA.,
- Affected lot / code info
- 2006-3627878
Why it was recalled
Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily recalling Black Ant because FDA laboratory analysis determined they contain undeclared amounts of sildenafil an active ingredient of FDA-approved drugs used to treat erectile dysfunction.
Recalling firm
- Firm
- Nova Products, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 5 Mount Pleasant Rd, N/A, Aston, Pennsylvania 19014-1407
Distribution
- Quantity
- Unknown
- Distribution pattern
- Nationwide to retailers and distributors
Timeline
- Recall initiated
- 2014-03-28
- FDA classified
- 2014-09-18
- Posted by FDA
- 2014-09-24
- Terminated
- 2015-08-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1597-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.