Green Planet Night Bullet Capsules Recalled for Unapproved Active Ingredients
Green Planet Inc is recalling Night Bullet Capsules because they contain unapproved active ingredients for erectile dysfunction.
The agency’s classification
FDA (Drugs): Class I
Class I is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Green Planet Inc is recalling Night Bullet Capsules, which are supplied in 1-count packets. The recall involves 429,619 capsules from Lot B43N032 with an expiration date of 10/15. The product was distributed nationwide.
The FDA is recalling the product because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The capsules contain analogues of sildenafil and tadalafil, which are active pharmaceutical ingredients in FDA-approved drugs used to treat erectile dysfunction. Consequently, the product is classified as an unapproved new drug.
Consumers who purchased these capsules should stop using them and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- Night Bullet Capsules, supplied in 1 count packets, produced by Green Planet Inc, Riverside, CA
- Manufacturer
- Green Planet Inc
- Category
- Drug — Unapproved New Drug
- Affected units
- 429,619
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# B43N032
- Exp 10/15
Distribution
Distributed nationwide across the United States.
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