Recalls / Class I
Class ID-0104-2018
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
PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718122032587
- Affected lot / code info
- Lot# NSS050888, EXP 05-2018
Why it was recalled
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Recalling firm
- Firm
- Gadget Island, Inc
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 5889 Central Ave, N/A, Newark, California 94560-4465
Distribution
- Quantity
- 89 1-capsule packets
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-09-15
- FDA classified
- 2017-12-04
- Posted by FDA
- 2017-12-13
- Terminated
- 2018-12-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0104-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.