Super Panther 7K Capsules Recalled for Unapproved Ingredients
Chiavna Saffron LLC is recalling Super Panther 7K Capsules because FDA analysis found the product was tainted with sildendafil and tadalafil and marketed without an approved NDA/ANDA.
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 source text explicitly identifies the agency classification as Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Chiavna Saffron LLC is voluntarily recalling Super Panther 7K Capsules 1250 mg blend. The recall involves 1 count blister cards shipped in boxes of 30 and 6 count bottles, distributed nationwide by SX Power CO. in Brooklyn, NY. The total quantity recalled is 211 bottles and 339 boxes.
The U.S. Food and Drug Administration (FDA) initiated this recall because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, FDA analysis determined that the product was tainted with sildendafil and tadalafil. The affected lots have expiration dates of 8/28/2020, with lot codes RO846356 and RO246852.
Consumers who have purchased these products should stop using them immediately. The recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- Super Panther 7K Capsules 1250 mg blend, a) 1 count blister cards shipped in boxes of 30 (UPC# 6015577513247); and b) 6 count bottles (UPC# 601577513209), Distributed by SX Power CO., Brooklyn, NY
- Manufacturer
- Chiavna Saffron LLC
- Category
- Drug — Supplement
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)
- a) RO846356 Exp. 8/28/2020
- b) RO246852 Exp. 8/28/2020
Distribution
Distributed nationwide across the United States.
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