PlainRecordsFDA · Drug recall
RHINO 7 Platinum 5000… and 3 more products
- Date
- Dec. 13, 2017
- Risk class
- Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)
- Status
- Terminated
- Filed by
- Gadget Island, Inc
- Reason
- Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
- Distribution pattern
- Nationwide in the USA
4 products in this recall
RHINO 7 Platinum 5000…
- Product
- RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packets, distributed by Fifty Shades Bayside, NY 11361, UPC 617135861224
- Quantity
- 925 1-capsule packets
- Codes and lots
- All Lots
- Recall started
- Sept. 15, 2017
- Recall number
- D-0103-2018
PapaZen 3300 capsule…
- Product
- PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 718122032587
- Quantity
- 89 1-capsule packets
- Codes and lots
- Lot# NSS050888, EXP 05-2018
- Recall started
- Sept. 15, 2017
- Recall number
- D-0104-2018
FIFTY SHADES 6000 capsule…
- Product
- FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading, UPC 4026666146056
- Quantity
- 273 1-capsule packets
- Codes and lots
- All Lots
- Recall started
- Sept. 15, 2017
- Recall number
- D-0105-2018
grande X 5800 capsule…
- Product
- grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana Seed 80 mg, Ginko Leaf 60 mg, Saw Palmetto 100 mg, Damiana Leaf 100 mg, Ginseng Root 80 mg, Tribulus Terrestris 90 mg, Tongkat Alo 100 mg, Rhodiola Rosea 60 mg, L-Arginine 90 mg), 1-capsule packets, distributed by Grande X Ontario, CA 91745, UPC 640793555440
- Quantity
- 198 1-capsule packets
- Codes and lots
- All Lots
- Recall started
- Sept. 15, 2017
- Recall number
- D-0106-2018
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement reports, recall numbers D-0103-2018, D-0104-2018, D-0105-2018, D-0106-2018. The agency record governs; check it and the company before acting.